DE-INCYTE
18.3.2022 14:58:06 CET | Business Wire | Press release
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology (AAD) Annual Meeting, held March 25-29, 2022, in Boston.
New 52-week data from the Phase 3 TRuE-V vitiligo program evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo will be presented as an oral presentation in a late-breaking abstract session. Incyte previously announced positive 24-week results from the TRuE-V1 and TRuE-V2 studies.
“We are pleased to convene again at AAD 2022 and present new ruxolitinib cream data which highlights its potential for patients with atopic dermatitis and vitiligo and our commitment to the Dermatology community,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “We look forward to sharing data from multiple Phase 3 studies highlighting clinical trial data for ruxolitinib cream – notably the 52-week results from the TRuE-V vitiligo program – as well as findings from the VALIANT study which contribute to the scientific understanding of the natural history of vitiligo and its burden on patients in the United States.”
Key abstracts include:
Late-Breaking Oral Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream Monotherapy for the Treatment of Vitiligo: Results from Two 52-Week Phase 3 Studies (Session: S026 – Late-Breaking Research: Clinical Trials. Saturday, March 26, 10:40 a.m. ET)
Posters with Oral Presentation
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Anatomic Region: Pooled Analysis From Two Randomized Phase 3 Studies (Category: Atopic Dermatitis)
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: Week 24 Pooled Analysis of the TRuE-V Phase 3 Studies (Category: Pigmentary Disorders & Vitiligo)
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo by Patient Demographics and Baseline Clinical Characteristics: Pooled Subgroup Analysis From Two Randomized Phase 3 Studies (Category: Pigmentary Disorders & Vitiligo)
The Mental Health and Psychosocial Burden Among Patients Living With Vitiligo in the United States: Findings From the VALIANT Study (Category: Pigmentary Disorders & Vitiligo)
Poster Presentations
Atopic Dermatitis
Long-Term Safety and Disease Control of Ruxolitinib Cream Among Black or African American Patients With Atopic Dermatitis: Pooled Results From Two Phase 3 Studies (Abstract #34794. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Ruxolitinib Cream Provided Progressive Improvement in Patients With Atopic Dermatitis Who Did Not Achieve Investigator’s Global Assessment Treatment Success at Week 8: Pooled Results From Two Phase 3 Studies (Abstract #35163. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Vitiligo
Exploring the Natural History of Vitiligo in the United States: Findings From the VALIANT Study (Abstract #34612. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Do Patients With Vitiligo and Healthcare Professionals Treating Them Recognize the Burden in Living With the Disease in the United States? Findings From the VALIANT Study (Abstract #34631. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Full abstracts will be available on the AAD website on March 25, 2022. More information regarding the 2022 AAD Annual Meeting can be found at https://www.aad.org/member/meetings-education/am22.
About Ruxolitinib Cream (Opzelura™)
Ruxolitinib cream (Opzelura) a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.
In October 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. Additionally, in December 2021, Incyte announced the acceptance and priority review of the supplemental New Drug Application (sNDA) for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with vitiligo.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura is a trademark of Incyte.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.
Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com .
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte .
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential of Opzelura to provide a successful treatment for atopic dermatitis, whether and when ruxolitinib cream might be approved to treat patients with vitiligo, the potential for success of such treatment, Incyte’s clinical trials and Incyte’s Dermatology program generally, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the FDA and other regulatory authorities; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended December 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220318005248/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Medisca Enters Its Next Chapter Under Founder Antonio Dos Santos29.6.2026 16:19:00 CEST | Press release
Medisca today announced that Founder and Chairman Antonio Dos Santos has returned to the role of Chief Executive Officer as the company enters its next chapter of growth. For more than 35 years, Dos Santos has helped shape Medisca into a global leader in pharmaceutical compounding. As Chief Executive Officer, he will lead the company's long-term strategy, with a focus on expanding Medisca's global reach, investing in new areas of growth, strengthening strategic partnerships, and continuing to advance the products, services, education, and expertise that healthcare professionals rely on every day. "When I founded Medisca, my vision was to raise the standard of pharmaceutical compounding by bringing pharmaceutical-grade quality to the industry and giving healthcare professionals access to the products, knowledge, and innovation they needed to deliver better patient care," said Antonio Dos Santos, Founder and Chief Executive Officer of Medisca. "That purpose continues to guide us. As we b
The Premier Jumping League (PJL) & McCarthy Jumping Team Announce Landmark Purchase29.6.2026 15:10:00 CEST | Press release
With $50 Million Team Acquisition, McCarthy Jumping Team Becomes First PJL Ownership Group Acquisition illustrates strong investor confidence in the future of professional showjumping as highly anticipated 2027 inaugural season to feature 16 teams competing across 14 international events The Premier Jumping League (PJL) today announced that seasoned trader, investor, and competitive race car driver Jason McCarthy and McCarthy Jumping League LLC acquired the first PJL team in a landmark $50 million acquisition, building on rising momentum for the highly acclaimed professional jumping league. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629512997/en/ The Premier Jumping League (PJL), photographed by Daniel Benson. The milestone investment represents an unprecedented valuation for a team in a newly established sports competition and underscores the confidence that sophisticated investors are placing in the PJL. The inaugur
InvestEco Sustainable Food Fund IV Holds a Final Close With Total Commitments of C$106M29.6.2026 15:00:00 CEST | Press release
InvestEco Capital is pleased to announce the final close of the InvestEco Sustainable Food Fund IV. This fund will continue InvestEco’s work of investing in high-growth food companies that promote health and sustainability in the food sector. The Fund closed with total commitments of C$106M, the largest InvestEco fund to date. Investors include Farm Credit Canada, Export Development Canada, Business Development Bank of Canada, Fonds de solidarité FTQ, and two Government of Canada Social Finance Fund wholesalers: Boann and Realize Capital Partners. In addition, the Fund received commitments from a number of private investors and family offices. The Fund's investments to date include Humble Snacks, Little Sesame, Mid-Day Squares and Algae Cooking Club. The Fund expects to make a further 6 - 10 investments over the next few years. InvestEco Capital, founded in 2002, is a Toronto-based venture capital firm and impact investor focused on the sustainable food sector. For more information, em
Geoswift and SKUx Announce Strategic Partnership to Develop a First-of-Its-Kind Programmable Stablecoin Commerce Network29.6.2026 14:00:00 CEST | Press release
Bridging digital assets, traditional finance, enterprise treasury, and agentic commerce through global programmable money infrastructure Geoswift and SKUx announced a groundbreaking partnership to develop a next-generation programmable stablecoin commerce network. This strategic collaboration bridges digital assets, traditional finance, and real-world commerce at a global scale, representing a "one-of-one" opportunity by combining Geoswift's global infrastructure with SKUx's specialized item-level controls directly within point-of-sale (POS) systems. While enterprise stablecoin usage continues to accelerate globally, governments, enterprises, payment networks, and AI-driven commerce platforms are increasingly seeking programmable payment infrastructure that can bridge digital assets with real-world commerce. The innovation goes far beyond treasury management or even enabling consumers to spend stablecoins at retail locations. Instead, it unlocks true "programmable money" with embedded
Esri Sponsors Smithsonian Exhibition Showcasing Natural and Cultural Objects from All 50 States29.6.2026 14:00:00 CEST | Press release
From These Lands Exhibition Highlights Connections Between People, Place, and Natural World Through Physical Specimens and Digital Maps Esri is the lead sponsor of the Smithsonian's From These Lands exhibition and developed maps powered by ArcGIS and a digital companion to extend engagement beyond the museum. The exhibition features more than 600 specimens and cultural artifacts from all 50 states, Washington, DC, and US territories, drawn from the Smithsonian's National Museum of Natural History's collection of over 148 million objects. Designed around themes of connection, diversity, and discovery, the exhibit explores how landscapes, ecosystems, and cultural traditions shape one another across regions and time. Animated mapping experiences enable visitors to explore topography, biomes, geology, migration patterns, and watersheds, revealing relationships across the continent. ArcGIS StoryMaps transforms the physical exhibit into an accessible digital narrative, extending its reach to
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom