Good morning, ladies and gentlemen, and welcome to Incyte's conference call and webcast to discuss Opzelura in vitiligo approval call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, you may press star one on your telephone keypad. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, today's conference is being recorded. It is now my pleasure to introduce your host, Ms. Christine Chiou, Head of Investor Relations. Thank you. Please go ahead.
Thank you, Donna. Good morning and welcome to Incyte's conference call and webcast to discuss the FDA approval of Opzelura for the treatment of non-segmental vitiligo, which was announced Monday, July 18. Speaking on the call today from Incyte are Hervé, Jim Lee, our head of development in inflammation and autoimmunity, and Todd Edwards, our dermatology business unit head. Barry, Steven, and Christiana will also participate in the Q&A session. I also have the pleasure of introducing Dr. Seemal Desai, a board-certified dermatologist in private and academic practice in Dallas, Texas, and clinical assistant professor in the Department of Dermatology at the University of Texas Southwestern Medical Center.
Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements and are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our reports filed with the SEC. We'll now begin the call with Hervé.
Thank you, Christine, and good morning, everyone, and thank you for joining today's call. I'm on slide four. Yesterday, we announced the FDA approval of Opzelura for the treatment of adolescents and adults living with non-segmental vitiligo. With this approval, Opzelura becomes the first and only approved treatment for repigmentation of vitiligo in the U.S. This is a momentous event for patients who have been suffering from this disease, which can often have significant consequences on patients' lives. We are incredibly proud to be the first company to provide an approved treatment option for vitiligo patients to regain their natural pigmentation. Turning to slide five. We are making significant progress with our dermatology pipeline.
We have obtained two important FDA approvals for Opzelura in less than a year, and we continue to pursue additional indications that may expand the use of Opzelura cream to other patient populations in need. Additionally, we are developing our oral JAK1 inhibitor, 707, in HS vitiligo and prurigo nodularis, all of which are in phase two. There is significant potential with each of these indications where there are limited treatment options and, in some cases, no FDA-approved treatment. Moving to slide six. We are establishing a high-growth dermatology franchise with multiple new opportunities for growth over the next two years. In addition to the launches of Opzelura in atopic dermatitis and vitiligo in the U.S., we could see a launch in Europe in the H1 of 2023.
Opzelura has the potential to be a substantial growth driver for Incyte, and the addition of new indications and new products like 707 will continue to solidify our dermatology franchise and allow us to significantly leverage our commercial operation. With that, I would like to turn the call over to Jim.
Thank you, Hervé, and good morning, everyone. Before moving into the highlights of the vitiligo label, I wanna touch on the pathogenesis of vitiligo that causes depigmentation and also provide an understanding of the unique way in which Opzelura works to help repigment the skin in patients living with the disease. Vitiligo is an autoimmune disease, and its pathogenesis can be attributed to several different factors. The dysregulation of the immune response, specifically the activation of skin CD8 positive T cells, appears to play a major role in vitiligo pathogenesis. This T cell activation causes the destruction of melanocytes and subsequently leading to the depigmentation of the skin. The cytokine interferon gamma plays an important role in the activation of the CD8 T cells, and its effects are mediated through the JAK-STAT pathway.
Opzelura is a topical JAK1/2 inhibitor, which works on the JAK-STAT pathway to block or suppress inflammatory cytokine signaling. By modulating the inflammatory response, Opzelura can create an environment that allows melanocytes to gradually regenerate, leading to the repigmentation over time. Turning to slide 11 and the highlights from the prescribing information. Opzelura is indicated for the topical treatment of non-segmental vitiligo in patients 12 years of age and older. The recommended use for Opzelura cream is to apply a thin layer twice daily to affected areas up to 10% body surface area or BSA. For reference, 1% BSA is the equivalent of the palmar surface of the hand, excluding the thumb. Looking further into the key features from the prescribing information. Opzelura is approved for continuous use anywhere on the body, including in sensitive areas, and there are no limits to the duration of treatment for vitiligo.
The 52-week efficacy data, which has been included in the label, demonstrates the continued improvement of repigmentation with longer duration of treatment. Additionally, the label notes that a satisfactory patient response may require treatment with Opzelura for more than 24 weeks, and again, highlighting the importance of staying on therapy. Slide 12 shows the 24-week efficacy data from both phase 3 TRuE-V studies. After treatment with Opzelura for 24 weeks, nearly 30% of patients demonstrated a 75% or greater improvement facial VASI, or F-VASI 75, and roughly 15% of patients were able to achieve a 90% or greater improvement in facial VASI. On the next slide is the 52-week efficacy data from the open label portion of the TRuE-V trials, which clearly shows that a higher proportion of patients responded to the longer duration treatment. Now moving on to the safety on slide 14.
The vitiligo safety data in the label, shown here, highlights the adverse reactions in greater than or equal to 1% of subjects treated with Opzelura through week 24. The continuous use of Opzelura cream over the 24-week period was well-tolerated and was not associated with any new safety signals. Application site acne was the most common adverse event and did not result in any study discontinuations. With regards to serious adverse events, the frequency was low, with none considered to be treatment related. Lastly, there were updates to the JAK class language in the warnings and precautions section. In this update, the box warning provides clarification as to the source of the JAK class warning, which now references a large randomized post-marketing safety study in RA patients with oral JAK.
Over the next few slides, I will share a few photos of patients and the results to illustrate what some patients can experience over time with Opzelura treatment. On slide 15, we have a 56-year-old male patient with disease duration of 21 years who had significant facial repigmentation at week 24 and continued improvement at week 52. On slide 16 is a 14-year-old patient with similar results, and again, the repigmentation appears to be closely matched to their unaffected skin. As we know, Opzelura cream demonstrates not only facial VASI response, but also total VASI response. On slide 17, we have a 66-year-old patient who has had vitiligo for 54 years. Her repigmentation improved with continuous treatment, and her total VASI score changed from 9.60 at baseline to 0.76 at week 52.
On slide 18, this is a 37-year-old patient with disease duration of eight years who had significant repigmentation response at week 52. She was shown to have repigmentation of her vitiligo on her hands, which is typically a very difficult area to treat. Lastly, I would like to end on slide 19, which shows facial VASI response by study visit from our pivotal program. What I really want to draw your attention to is the response times in patients that were seen in the clinical trials. You can see here that at week 12, almost 50% of patients achieved at least a 25% improvement in facial VASI from baseline, demonstrating the early response seen in many patients. The vast majority of patients experienced an improvement in repigmentation, with nine out of 10 patients achieving a facial VLASI 25 by week 52.
This demonstrates that improvements in repigmentation were observed in most patients with continued treatment beyond 24 weeks. With that, I would like to turn the call over to Dr. Seemal Desai, a leader in the field of dermatology and a recognized expert in the treatment of vitiligo.
Well, thank you again for that kind introduction, Jim, and it's really a privilege to be here with the team to talk about such an exciting development in the world of vitiligo. As was mentioned, my specialty and focus in dermatology is in the management and treatment of pigmentary diseases, and my practice in particular focuses on vitiligo. This is certainly very, very exciting for both my patients and for me, both as a physician expert in treating the disease and the family member of someone who suffers from vitiligo. This is equally, if not more impactful. Just to recap, let's talk through a few things we know about this disease and where we're at in our understanding on the pathogenesis of vitiligo. This is a disease that I would say is not rare.
One of the important things to realize is that the prevalence of vitiligo in the United States and Europe is between 1%-3% depending on the data you read. This is not something that is you see one case a year or two cases a year. This is fairly common, and most often this can happen in patients from a variety of different ages. Now, over half of the patients who suffer from vitiligo tend to show signs before the age of 20. However, this can be seen in pediatric patients, adolescent patients, young and old adults, and equally distributed amongst male and females.
Here are some examples you can see of disfiguring vitiligo in patients with skin of color, where certainly this has a profound psychological impact, looking at the discordance both in natural skin tone and the depigmented white patches in other areas of the body as well, as you can see. Now let's move to the next slide. Here, you see an additional amount of clinical images. Now, this is a disease that can affect small body surface areas, large body surface areas, small areas in circular patterns, arcuate patterns, the hands, the neck, as is shown here. Keep in mind that vitiligo is one of these diseases that I tell my patients can technically affect any part of the body.
The tough part for many patients who suffer from this to understand is there's no way to predict which part of the body surface area is going to be affected. I've had patients who have localized small disease for many years, and then I have patients who have very large body surface area as well. Now, I will point out that here you see the picture of the bilateral dorsal hand and acral vitiligo on the hands and feet, I would say are the most difficult, challenging areas to repigment. That's because those areas tend to lack a lot of hair follicles where the pigment melanocytes can return from. This is really exciting because Opzelura really for me in my practice, has been a game changer for treating patients with vitiligo, and I'll talk about that in just a few moments.
Let's move to the next slide. Here again, you see a clinical image. Now in this case, this refers to what I alluded to earlier, widespread disease. Look at the truncal involvement, the large patches on the central chest, the abdomen. If you think about how to treat this patient who is suffering with widespread involvement, you can imagine that it's going to be something that is not only going to be psychologically challenging for the patient, but also can be challenging for us as the dermatologist, because you're going to have to figure out multiple modes of therapy. Of course, there's a variety of different treatment options in our therapeutic armamentarium, such as narrowband UVB, excimer laser phototherapy, combination prescription-based medications, which up until now have been off-label.
With the FDA approval of Opzelura, we now have a historic step in our journey to curing this disease one day, which is the first ever FDA-approved treatment to repigment vitiligo, which is why this is so exciting. Now, with this in mind, let's talk about the impact of vitiligo on patients on the next slide. I will tell you that vitiligo has been associated with a variety of psychological impacts and burdens of disease. This is a very stigmatizing, challenging condition. It's very tough to treat, as I've mentioned, and it's important to keep in mind that many of these patients oftentimes lose hope.
To now be able to share with my patients that we have an FDA-approved therapy, a brand-new mechanism of action in the world of vitiligo, which up until now has been studied in off-label, but now is something that I can prescribe to my patients with data and with confidence and with excitement, I think is going to be something that really allows our patients to have a lot of hope. That's one of the things that myself as a vitiligo specialist and many of my other dermatology colleagues who I lecture to around the world need to be able to share with these patients, is that there is hope, and we're reaching a point in our vitiligo research journey where there's exciting treatments that are now available and hopefully more to come.
With that being said, let's move to the next slide and talk about management of vitiligo. There are lots of different ways to treat this disease. You can do everything from topical treatments with topical steroids, topical calcineurin inhibitors. Now with Opzelura, topical JAK inhibitors with the ruxolitinib 1.5% cream. You can do systemic steroids to stabilize active disease, use phototherapy like narrowband UVB and excimer laser, surgical modalities, and also for patients who are suffering from this psychologically, as I've mentioned a few times already, psychiatric and psychological involvement is something that I do employ in many of my patients as well as in families, because this is a disease, depending on from what culture you're from, what part of the world you're from, there are lots of sociocultural implications to developing vitiligo.
It's always important to analyze the patient's desire and ask the patient, "What part of your body bothers you the most? Is there an area of your vitiligo that you're more concerned about? Is there an area that you're not concerned about, that you've just learned to live with and really don't want to have treated?" It's very important to customize the regimen for the patient. That's where I think Opzelura really plays an important role in both my practice up until now off-label, and now I can say I'm doing an FDA-approved therapy for the first time ever for this disease. Let's move to this slide entitled Opzelura in vitiligo. This is really groundbreaking. Opzelura is a therapy that really offers our patients so much hope.
Repigmentation in typically difficult to treat areas, including the hands, precision of color match of repigmentation, robust results early in the treatment process, and the fact that this is not a steroid. It can be used on the face and other sensitive areas. This is non-steroidal. In addition, we have prescription flexibility. Keep in mind, when you read the package insert, we have flexibility in duration of treatment. We have flexibility in the fact that we can use with phototherapy. We have flexibility in the fact that this can be used on a variety of different body surface areas. We have flexibility in the fact that this can be used monotherapy.
What's really exciting for me, both as an investigator who was involved in the clinical studies, as well as a clinician specializing in this disease, is that I'm now able to offer my patients something that's non-steroidal with no limitations on body surface area because I can use it on the face and other sensitive areas, and I can potentially treat these patients monotherapy with an FDA-approved cream like Opzelura. Let's move to my final slide and kind of wrap this up. Opzelura is a game changer in our treatment armamentarium for vitiligo, and it is, in my mind, for my patients and my practice, going to be and has become the first-line option for the majority of vitiligo patients seeking therapy.
It's important to think about this in the context of using this in less than 10% body surface area per the package insert in areas that are most likely to respond and benefit, such as the head and neck. Remember earlier I mentioned the hands are extremely difficult. Well, guess what? You can also try this on the hands or the feet. In clinical trials, we were one of the investigator sites, this did work on acral vitiligo. I think it's important to set expectations for patients. These are my experiences as a vitiligo expert. Keep in mind, patients have been waiting a very long time for an FDA-approved therapy that actually works, that delivers results, that has a scientific basis and mechanism with this JAK inhibition of actually repigmenting their disease.
I couldn't be more excited about this, and I hope that this brief clinical overview has been helpful as we continue to share the message about Opzelura and its role in treating vitiligo and repigmenting this very devastating and challenging condition. With that, I'd like to thank everyone at Incyte for inviting me. I hope that this was helpful to all of you joining in, and I'll turn it back over to the team.
Thank you, Dr. Desai. I'm very excited to be here today to provide a high-level overview of our plans for the commercial launch of Opzelura in vitiligo. We have heard from Dr. Lee and Dr. Desai about the impact this disease has on patients. I want to take a moment to share with you a brief testimonial from a patient about his experiences, both living with vitiligo and with Opzelura treatment as a participant in our clinical trial. Operator, please play the video.
I live in Whittier, California. I have lived with vitiligo for over 30 years, since the age of 10. When my vitiligo started to progress rapidly, I started seeing a lot of changes in my hands, then my elbows, and then my face. I tried from creams at a young age with 1% of vitiligo disappearing, UV lighting with no changes at all, and vitamins, exactly the same thing, nothing. It started progressing a lot due to the stress. That's why I left the military and I left being an air traffic controller. I lost hope in knowing that the treatments that I tried weren't getting me nowhere. The decision was made, either is I can crawl up into a little space with a little ball and cry all day long about it or just continue my normal life.
The measures that I took to hide my vitiligo was an extreme. I started using makeup. I used hats, sunglasses, long-sleeve shirts, gloves, and an umbrella walking outside in the sun. When I learned about the clinical trial that I was accepted, it was exciting. Also, at the same time, I did not have high hopes for it, due to the fact that previous treatments were unsuccessful. When the pigment returned after a few months of starting the treatment, was very satisfying. It came with news from my wife. She's the one that saw it first. At the time, I was very sad. I was saying, "Another treatment, no results." When she says, "Hey, you have pigment on your eyes. Look in the mirror," I was very happy. The goals that I achieved with this clinical trial was tremendous.
I saw repigmentation coming back onto my face, hands, and body in less than six months. I started out with the treatment at six months, having just a few pigments on my skin. A year into it was more than 60% of vitiligo on my facial surface was gone. Two years into it, I only have 5% of vitiligo on my face. The results of this clinical trial made me feel like I was normal again. I started coming out of my shell, talking more to people eye to eye, and having more of a social life. I plan to stay on this treatment because this is the first treatment that has made a significant impact on my vitiligo. To have the first FDA-approved vitiligo treatment is superb. I'm very happy.
I'm happy for myself, for the vitiligo community, that there is hope at the end of the tunnel.
There are over 1.5 million people diagnosed with vitiligo in the U.S., and we hear repeatedly from patients about the challenges they face on a daily basis while living with their disease. These challenges are often associated with a psychological burden, with many patients reporting depression, anxiety, stigmatization, suicidal thoughts, and loss of self-esteem. Until now, there has been no approved therapies for repigmentation, and the treatment that have been available today have significant limitations. Despite this, there are 150,000-200,000 people living with vitiligo in the U.S. who are actively seeking treatment. Slide 31 shows a representation of what has been a typical vitiligo patient's treatment journey. At the beginning of the treatment cycle, dermatologists are likely to set expectations with regards to treatment outcomes for their patients.
Over the next 6-12 months, a patient may try topical therapies, phototherapy, or a combination of both, and may feel anxious or unsure of what to expect. Many patients are often left with feelings of high treatment burden and/or unsatisfactory responses from their treatments. While some patients will seek more aggressive options like systemic therapy or choose to stay on topical therapy indefinitely, the majority of patients end up frustrated, disappointed, and discouraged. They may cycle through additional therapies, be told there are no other options, or may stop seeking treatment altogether. Patients often believe nothing will be effective for their disease, and they resign themselves to living with vitiligo. We have an unprecedented opportunity to break this treatment cycle to offer patients a new therapy with proven results. As Jim showed earlier, repigmentation improvement occurs in the majority of patients treated with Opzelura by week 52.
The cream, which is light, non-greasy, and easy to apply, was well tolerated and can be used continuously, including on sensitive areas. The uniqueness of Opzelura's profile offers physicians a novel, effective therapy to treat vitiligo, and we believe it will truly change the treatment landscape for physicians and significantly improve the treatment experience for patients. Moving to slide 33. I would like to touch on our launch strategy, starting with physicians. Based on a survey of over 250 physicians treating vitiligo patients in the United States, the top treatment goal reported was repigmentation of affected skin. The substantial improvement in both facial and total VASI with Opzelura was demonstrated in the largest positive randomized clinical trial in vitiligo, and our dermatology team will be able to share these compelling efficacy data with physicians.
Similar to our launch in AD, we are focusing our efforts on dermatologists, where the majority of vitiligo patients are diagnosed and treated. There is near complete overlap between our vitiligo and AD targets. Of our high decile dermatologists, many of whom are top targets for both indications, over 70% of physicians have written a prescription for Opzelura in AD. Satisfaction rates of both prescribers and patients remain very high, which may benefit in the adoption of Opzelura in vitiligo. When we surveyed a sample of 100 physicians, roughly 90% indicated a willingness to prescribe Opzelura for vitiligo, regardless of previous experience with Opzelura. Additionally, these physicians believe that roughly 80% of their entire vitiligo patient population are appropriate candidates for Opzelura.
We will be launching a comprehensive multi-channel marketing campaign that will ensure broad and consistent reach to effectively drive awareness and educate physicians on the approval of Opzelura and its unique clinical profile. Turning to slide 34. Our strategy with patients involves engaging those who are actively seeking treatment, whether they are newly diagnosed or existing patients, as well as those who may have given up hope for an efficacious option following years of disappointing results. At launch, we will have an active media campaign to drive awareness, including a strong presence on a variety of social media platforms where we know patients are seeking information. We are also working with patient advocacy groups and are launching with a robust offering of educational resources, co-pay mitigation, and other support programs to drive access to Opzelura.
With regards to timing of more traditional TV DTC, we expect to start early next year once all regulatory timelines are met post-launch. Turning to slide 35. We continue to make significant progress on the payer front with Opzelura. We have now signed contracts with the three largest PBM GPOs, covering nearly 80% of all commercial lives. With these contracts, we have been able to establish coverage for Opzelura. Payers must now assess the Opzelura vitiligo labeling to establish utilization management criteria for vitiligo patients. We are fully prepared for a very successful launch in vitiligo. With that, I will pass the call back to Hervé.
Thank you, Todd. I'm on slide seven. As you have heard, we are well positioned to drive further growth of Opzelura. We are in a unique position to be launching the first ever approved therapy for repigmentation in vitiligo and with a very good label. Vitiligo represents a large market opportunity in the U.S. and we believe Opzelura will change the course of treatment for many patients. For our launch in vitiligo, we expect to capitalize on the success we have seen in atopic dermatitis. With our established dermatology commercial team, we will be able to leverage the existing relationships with physicians and payers to build upon the excellent progress we have made thus far.
This approval marks an important second step for Incyte Dermatology in becoming a large, established, and successful franchise, and we will continue to look for avenues to maximize the opportunity with Opzelura as well as with 707. Now, operator, please open up for Q&A with the Incyte team. Thank you.
Thank you. Ladies and gentlemen, the floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. If you would like to remove yourself from the queue, please press star two on your telephone keypad. We do ask that you please limit yourself to one question and one follow-up. Again, that is star one to register a question at this time. Today's first question is coming from Brian Abrahams of RBC Capital Markets. Please go ahead.
Hi. Good morning. Thanks for taking my question, and congratulations on the approval. The data's, of course, shown substantial improvements that continue into 52 weeks, and the label makes it clear that the best results may take more than 24 weeks to achieve. I guess first off, for Dr. Desai, I'm curious your expectation for how patient individuals with vitiligo are gonna be for the repigmentation process and what proportion of your patients you expect are gonna stay on beyond the initial six-month assessment time points and ultimately use the drug beyond a year and chronically. I guess for the company along those lines, any new work you expect you'll need to do from a commercial standpoint to educate around the benefits of longer-term use, which is of course distinct from the atopic derm use patterns.
Given some of the reception, the favorable reception you're hearing in the market research, whether we should be expecting a bolus of patients to accelerate the current launch into year-end, or if this is gonna be more of a long-term contributor, indication? Thanks.
Hi, this is Jim Lee. Dr. Desai is not able to join us on the Q&A. Perhaps I can address your first question and turn it over to Todd for your second question. We anticipate that, you know, the duration of treatment will really depend on the patient's motivation. I mean, in the clinical trials, the vast majority of the patients stayed on the therapy. I think you saw that from the patient video. In terms of the duration, you know, we have an ongoing study where patients are continuing with another year of continuous therapy and the results look very good. Hopefully we'll be able to share that with you next year. You know, from a clinical trial perspective, the vast majority of patients continued with ruxolitinib cream therapy.
Thank you, Jim. Brian, in reference to your question about the commercial work that needs to be done to distinguish vitiligo relative to patients, we wanna ensure a best-in-class experience from the start. Our tactics first focus on priming people with vitiligo for effective and productive conversations with their HCPs. Then we want to ensure that potential patients are able to access Opzelura with ease while also understanding that gradual repigmentation process and that it will take time. Tactically, this is gonna be supported by opzelura.com website, and a CRM experience will be engaging patients through email, text, and direct mail. In addition to that, we'll have the active media campaign and social media.
Furthermore, to continue to support patients on this journey, we've created a mobile tracking application, along with a habit tracker and patient journal that can be accessed through opzelura.com or website or a direct mail with a QR code to help patients understand what that journey looks like, treatment expectations, and the need to make certain that they stay compliant with Opzelura throughout that journey. In reference to your bolus of patients for vitiligo, as mentioned, we have a really unprecedented opportunity here with the uniqueness of Opzelura. You think about the size of the opportunity, it is actually quite large with 1.5 million patients being diagnosed. However, it's difficult to predict the speed of launch or whether it'll be a bolus of patients.
'Cause today, as mentioned, there's 150-200 thousand patients who are currently seeking the treatment, and these patients may be more inclined to see their dermatologist or to become aware of Opzelura. However, as mentioned, there are others who have stopped seeking treatment, and it may take time to become aware of the therapy, schedule a visit with their dermatologist, and then make a decision to seek treatment or not.
That's really helpful. Thanks so much. Congrats again.
Thank you. The next question is coming from Tazeen Ahmad of Bank of America. Please go ahead.
Hi, good morning. Thanks for taking my question, and congrats on the second approval for Opzelura. I just wanted to ask about how this new approval is going to impact the discussions that are underway already for Opzelura getting onto formulary. You do have a couple of moving parts. I think scripts this quarter for AD might indicate that you're in process of shifting some patients in AD over from free drug to paid status. For the companies that you've negotiated with where they will reimburse Opzelura, will that be for both indications, or will vitiligo need to be separately discussed? Secondly, I guess if you were to compare the two launches, what would be a specific hurdle to vitiligo that you may not have faced for atopic derm? Thanks.
Yes, that's a really good question, and there are very separate moving parts relative to the access. As mentioned, you know, we have signed the contracts with the largest PBMs and GPOs, which cover nearly 80% of the commercial lives. I just want to remind you that these contracts cover the end market 60-gram tube and are not indication-specific. Thus, Opzelura NDC blocks are in the process of being removed. For the payers, we anticipate the next step would be able to review the label for vitiligo and then manage the prior authorization and utilization management criteria for a vitiligo patient. This can take anywhere from a few weeks to several months.
Relative to what that means for a vitiligo patient is for a vitiligo patient where a payer has a current vitiligo policy in place today, that patient will need to access vitiligo through a prior authorization process. If Opzelura is covered under that policy, it's very likely that that patient's Opzelura will be covered. If the PA is denied, then we have a program in place today for PA denied to make certain that that patient has access to Opzelura to be able to have a trial of the product, which we believe will lead to rapid adoption. Relative to hurdles with vitiligo that we didn't face in AD, I think one of our largest hurdles is activation of the patients.
When we give thought to the number of patients that have been frustrated and disappointed with the current treatment options that have been in the market, we need to make certain that we can reach out, create awareness to those patients and to have them actively seek treatment through their dermatologist.
Next question, please, operator.
Thank you. The next question is coming from Srikripa Devarakonda of Truist Securities. Please go ahead.
Hi. Congratulations on the approval and also the broad label, and thank you so much for taking my question. I know you touched upon it a little bit, but Dr. Desai talked about how patients had given up hope. What do you think it will take to get these patients to actually come back to the clinic and seek treatment? You know, he also talked about how important it is to customize therapy. You know, our research suggests that patients typically focus on hands and face. Based on the data that you've seen from the trials, what are your expectations?
Sure. This is Jim Lee. Maybe I can address your second question regarding the customization. As Dr. Desai mentioned, the thing that drives patients or most impacts them is the depigmented areas on the visual areas, the hands, the feet, the neck, and the face. We studied all of those areas in the clinical trials. There was no limitations in terms of, you know, anatomic site, and we saw a good gradual response, obviously in all the areas. The face is always the fastest to repigment, and the hands, as Dr. Desai mentioned, the hands and the feet are the slowest. We did see a response in all of the areas.
I think that data will provide important information for the physician to discuss potential treatments with their patients. As Dr. Seemal Desai mentioned, there's no therapy available for these patients. We believe, you know, we're very happy to offer something up. I think we believe that these patients will seek to talk to their doctors and see if Opzelura is the right treatment for them. Maybe I'll ask Todd Edwards to address your first question.
Yeah. For the patients, what it will take to have them to come back to therapy. If you think about it, these patients have had no viable treatment option since their time of diagnosis. There's a significant unmet need with these patients in the market. I think what's gonna compel them is to really start to understand that there is now a very meaningful treatment option that is available, that has proven clinical data and has demonstrated results for vitiligo patients. It is our task then to make certain that we can create that awareness to those patients, which as mentioned, we are going to engage patients where we know they seek their information to inform them, to educate them, and then to provoke them to seek that appointment with their dermatologist.
Great. Thank you. If I can ask a follow-up question. In the longer run, given the competition you've seen in atopic derm for Opzelura and given that you're the first approved drug for vitiligo, do you see vitiligo being a larger market or a greater focus for your derm franchise compared to atopic derm?
Hi, this is Cristiana. We believe that vitiligo represents a very significant opportunity given the number of patients. You have 1.5 million diagnosed in the U.S., and the fact that there are no other efficacious therapies available and no therapies that have been approved for repigmentation. Having said that, at this point, we are not going to be giving guidance on how big we see this opportunity. The reason for this is that, until now, there were no other efficacious therapies available for patients, and as a result, only a small number of patients, 150,000-200,000, were seeking treatment. We believe that this will change now that we have Opzelura approved for vitiligo, and you heard Dr. Desai calling it a game changer.
We want to see more data on the launch, on how patients are coming in, on utilization in real life before we tell you more about the how big we see this opportunity being in the long term.
Great. Thank you so much for taking my questions, and congrats once again.
Thank you. We are asking analysts to please limit themselves to one question to allow for as many questions as possible today. Our next question is coming from Jay Olson of Oppenheimer. Please go ahead.
Oh, hey, congrats on the approval, and thank you for the update. My question is logistical. Can you tell us if you'll be breaking out Opzelura revenues or scripts by indication so we can track the progress of the vitiligo launch? Related to that, what lessons did you learn from the launch of atopic dermatitis that you can apply to the vitiligo launch? Thank you.
It's Todd. At launch, we will not be breaking out the prescriptions by indications. We'll need some time to be able to see how reliable the available data is and to assess that. In reference to what some of the lessons learned relative to the AD launch and to this vitiligo launch is one, relative to payer access and how that resonates with an HCP and their understanding not only of the access, but what is the process.
What I mean by the process is the prior authorization process and how do we make it a smooth transition, not only for these physicians, but also for the patients as they go through that prior authorization process and understanding what needs to be accomplished, the timing to do that, and to access their Opzelura. Furthermore, it will be different in vitiligo as it will be for AD because at the AD launch, we had no access, and a majority of the business was NDC blocked. As you're aware, we made great progress for Opzelura. For the vitiligo patients, it'll be more about the prior authorization process and how do we enable that process to support them and their providers.
Super helpful. Thank you very much.
Thank you. The next question is coming from Salveen Richter of Goldman Sachs. Please go ahead.
Thank you for taking my questions, and congratulations on the approval here. The label allows for continuous use, but what are your expectations on duration of use in the real world, and what has doctor feedback been here?
This is Jim Lee. Maybe I can address the first part of your question. In terms of the duration of use, we anticipate that the patients will treat for a long time. The reason I say that is in the clinical trials, we saw a very good compliance over a year. As I mentioned earlier, we have an extension study for an additional year, and we've seen a very high rate of compliance of patients who wanted to continue therapy. Ultimately, the duration will depend on the patient and what they're expecting in terms of the repigmentation. It's hard to say what patients will want in the marketplace. In the clinical trials, we had a very high compliance rate with the extended duration of treatment.
Yeah, this is Todd. Relative to your second question about doctor feedback. The doctor feedback has been incredibly positive relative to Opzelura and vitiligo. Doctors have been challenged in providing, you know, their patients, you know, viable treatment options, and it's been a frustrating experience not only for the patient, but also for the provider to be able to meaningfully treat them. To have a product now that has demonstrated data with proven results that it will provide a meaningful treatment option for patients, the doctors are incredibly excited, very optimistic, and are eager to initiate therapy on patients.
Thank you.
Thank you. The next question is coming from Cory Kasimov of JP Morgan. Please go ahead.
Hey, good morning, guys. Thanks for taking my question. Curious if there's any reason to expect any material differences in relative gross to net for vitiligo versus atopic derm, or for this added indication to impact that trajectory in a meaningful way. Thank you.
No, we are not assuming any meaningful impact to gross to net for this indication.
Great. Thanks.
Thank you. The next question is coming from Michael Schmidt of Guggenheim Securities. Please go ahead.
Hey, guys. Thanks for taking my question. I had another one on the label, maybe for the physicians. That language about 10% body surface area, you know, how will that affect the use of the drug? Perhaps comment about, you know, what percentage of patients has impact in more than 10% of their body surface area. Thanks so much.
This is Jim. No patients with greater than 10% body surface area were allowed in the study. We know the vast majority of patients have 10% or less body surface area involvement of their vitiligo. That was really the intent of the clinical trial design based on input from vitiligo experts. The vast majority of the patients have 10% or less. You know, part of the reason is if you have extensive involvement, it's harder to treat with a topical therapy for an extended period of time. We wanted to really focus on the patients who were amenable and targets for topical treatment. Again, our data shows that 80% of the patients out there with vitiligo have 10% or less. It's great to be able to offer a topical treatment for these patients.
Okay. Thank you.
Thank you. The next question is coming from Marc Frahm of TD Cowen. Please go ahead.
Hi. Thanks for taking my questions and congrats on the new approval as well as Todd, congrats on getting the third PBM GPO under contract earlier this quarter. Now that you have that in place, you mentioned, you know, you're working through the utilization management process for AD. I guess, maybe could you give us a sense of where that is? Like, what percent of lives of those 80% of lives that are covered by the GPOs and PBMs and HMOs are covered by utilization management decisions already? You know, how quickly do you think vitiligo can kind of catch up to that process, you know, given that the contracts over top are already in place? As those decisions come in place, what type of restrictions are you expecting, in terms of either starting therapy or also to kind of continue in that chronic phase?
Hi, Marc Frahm. It's Cristiana. On the AD data and where we stand with covered lives, et cetera, we will be providing an update on our Q2 earnings call in a few weeks. We'll not be addressing any updates on AD at this point.
This is Todd. In reference to the Vitiligo and the utilization management criteria, we did an assessment across the payers and PBMs to evaluate the percent of medical policies that are currently in place for Vitiligo, and there's approximately 55% of the payers do have policies in place today. However, some of those policies will need to be updated after the payer has the opportunity to review the Vitiligo label. Prior to the approval, our medical affairs team has been intensely engaging the payers to inform them relative to the clinical value of Opzelura, and we've had very productive conversations with them. For the Vitiligo patients where the payers do have policies in place and will cover Opzelura, those patients will need to go through a prior authorization process.
Now, what that prior authorization process could look like, it could be currently what the status is for Opzelura today. It could be a single or double step edit through a TCS and/or a TCI. However, as payers evaluate the label and update those medical policies, and establish specific prioritization and utilization management criteria, that could likely change. Because there is no other FDA-approved products in the market, the prioritization of step edits could be that Opzelura is a first-line therapy and/or it could include a trial of a TCS or TCI.
Okay.
Thank you. The next question is coming from Vikram Purohit of Morgan Stanley. Please go ahead.
Good morning. This is Kaspar on for Vikram. We have one question. Incyte has previously guided to 10+ tubes of use per year for vitiligo. Does that guidance still stand?
Yes. Hi, this is Jim Lee. Yes, it does. We still believe that on average, patients with vitiligo will use approximately 10 tubes per year.
All right. Thank you very much.
Thank you. The next question is coming from Reni Benjamin of JMP Securities. Please go ahead.
Hey, good morning, guys. Thanks for taking the question and congratulations on the approval. Can you just comment a little bit on, you know, the interactions with dermatologists to date? Not, I guess, whether or not they would prescribe vitiligo, I think you mentioned 90% would, but do they have patients that, you know, they are either already treating or patients that they've seen, you know, that have vitiligo? You know, roughly how many of those physicians do you think would start prescribing right away? Thanks.
Yes, this is Todd. As mentioned, there's approximately 150-200 thousand patients that are being treated today for vitiligo. We expect that those patients will keenly become aware of Opzelura and ask questions relative to their dermatologist about that as a treatment option and think that will happen fairly quickly. Relative to...
How many-
Sorry.
As a proportion of physician-
Yeah, proportion of physicians. My apology. Proportion of physicians that will prescribe vitiligo. As mentioned, with our target overlap for AD and vitiligo is 98%. Then when we did a survey of physicians, 70% of those physicians stated that they would prescribe vitiligo, excuse me, Opzelura for their vitiligo patient. We expect with this being the only FDA-approved treatment option and that there has been no other treatment options available that dermatologists will be eager to start patients on this therapy.
Thank you. The next question is coming from Evan Seigerman of BMO Capital Markets. Please go ahead.
Hi there. This is Connor MacKay on for Evan. Thanks for taking our question. We just have one question. The revised indication for Opzelura suggests that usage beyond 24 weeks is acceptable in patients who have a satisfactory response. Would you just be able to expand a little bit on what you mean by satisfactory? Thank you.
This is Jim Lee. In terms of the satisfactory response, that's guidance to the physician. It says the physician and the patient should select or decide if they wanna continue treatment or not beyond the 24 weeks. That's really all that line was intended for. It's really to assess a patient's response at 24 weeks. The patient, in the rare instance that they are not responding at all, obviously they should reconsider the continued use of Opzelura. As the 52-week data shows in the label, I think you'll see it shortly, the vast majority of the patients continued to improve. We anticipate that most of the patients will treat beyond 24 weeks.
Thank you. The next question is coming from Matt Phipps of William Blair. Please go ahead.
Good morning. This is Rob Andrew in for Matt Phipps here. I'll add our congratulations on the approval here. you know, you mentioned earlier in the call some updates on the specificities in the safety label related to kind of mortality, MACE being in the setting of rheumatoid arthritis with oral JAKs. also looks like there were some updates in terms of kind of malignancies and thrombosis, more specifically related to Opzelura. maybe you can just discuss those a little bit. I know we lost Dr. Desai here for the physician perspective, but you know, how do you anticipate that that's gonna affect the kind of patient-prescriber thought process on Opzelura here? just secondly, I don't think on slide six there was any mention of AD in Europe.
I know the plan had always been to launch vitiligo first there, but just wondered if you could address European plans for an AD launch as well? Thanks.
This is Jim Lee again. Let me address the questions around the updated safety labeling. As I mentioned in the presentation, the box warning was updated to reflect the standardization of the language for the JAK class to specify the source of any of the adverse events that were reported in a RA study. In terms of the specific updates, we really didn't have specific updates from, or changes from the AD label. There were some events that were reported in the vitiligo clinical trials, but we believe that they were not related to treatment. We disclosed all of the events that occurred and the updated safety section is indicative of the data that we collected in the phase 3 program. In terms of the European question, I'll turn it over to Hervé.
Yeah, maybe I can take it. The submission in Europe is in vitiligo. The expected review time would lead to end of the year or more, somewhere there, depending on the, you know, some you know, review delays or not, but somewhere by the end of the year. The reason why we wanted vitiligo is very clear. It's because there is no approved therapies, so the pricing, which in Europe can be brutal, would be easier if we had an indication where there is nothing else approved. In terms of AD, we have not given up completely. We are looking at what could be potentially indications that would be limited in some way and would allow us to have the same price as what we expect to get in vitiligo. As of today, there is no submission in atopic dermatitis.
Yeah, this is Todd. Relative to your question about the box warning. You know, physicians will give consideration to the box warning and other factors to be able to make an informed treatment or recommendation. Specific to Opzelura for vitiligo, I think some of those key considerations will be the unmet need, as well as the availability of any other viable treatment options. Then finally, that there were no new safety signals with continuous use of Opzelura in vitiligo, and it was well-tolerated profile with the most common adverse event of acne.
Thank you. Ladies and gentlemen, we have gone through all of our questions for today. We would thank you for your participation and interest in today's topic. You may disconnect your line to log off the webcast at this time, and enjoy the rest of your day.