DE-INCYTE
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
Clarity AI Acquires ecolytiq, Further Expanding Its AI Sustainability Solutions to End Consumers9.7.2025 13:00:00 CEST | Press release
The acquisition expands on Clarity AI’s market leading climate engagement offering for global retail and commercial banking financial institutions Clarity AI, one of the world’s largest and most awarded technology and AI firms in sustainability, today announced the acquisition of ecolytiq, a leading provider of in-app climate engagement solutions for financial institutions and their millions of retail and commercial banking customers globally. This strategic move further reinforces Clarity AI’s position at the forefront of the rapidly expanding sustainability tech sector, strengthening its dominance in delivering impactful, data-driven solutions that empower individuals and organizations to make more sustainable choices. With this acquisition, Clarity AI expands its class-leading product portfolio, serving a broad spectrum of market participants—from institutional investors and global corporations to retail banks and individual consumers. The company’s modular, AI-powered platform is d
Valorem Reply Brings AI-powered Image Recognition to Art Basel’s Global Fairs9.7.2025 12:57:00 CEST | Press release
Valorem Reply, part of the Reply Group and focused on delivering innovative digital solutions with Microsoft technologies, partnered with Art Basel – a premier international art fair that hosts shows in Basel, Hong Kong, Miami Beach, Paris and Qatar – to enhance the visitor experience. In partnership with Microsoft, they developed Art Basel Lens, a feature within the Art Basel Companion app that uses image recognition to provide real-time information about artworks directly to visitors’ smartphones, making it easier to explore and engage with the art on display. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250709262853/en/ With Valorem Reply, Art Basel introduced a mobile image recognition feature that connects audiences to artworks using Microsoft Azure. By scanning an artwork, visitors receive structured content about the piece, the artist, and the gallery. The feature supports a more autonomous and fluid exploration of
Venture Global andSEFEAnnounceExpansion of LNG Partnership9.7.2025 12:19:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and Securing Energy for Europe GmbH (SEFE) announced the finalization of an agreement under which SEFE’s subsidiary, SEFE Energy GmbH, will purchase an additional 0.75 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from CP2 LNG, Venture Global’s third project, for 20 years. Today’s announcement amends the existing Sales and Purchase Agreement signed by the companies in 2023, increasing the total volume of LNG purchased by SEFE from CP2 LNG to 3.0 MTPA. Venture Global is expected to become Germany’s largest LNG supplier, with a combined 5 MTPA of 20-year offtake agreements signed with SEFE and EnBW. In addition to its existing long-term agreements, Venture Global to date has supplied Germany with almost 80 cargoes of LNG from its Calcasieu Pass and Plaquemines LNG facilities, enough to power 8 million German homes for one year. “Venture Global is thrilled to expand our strategic partnership with Germany and SEFE and play a leading r
The MasterFrame 600, Cooler Master's Modular Full Tower for High-End Builds, Now Available in Europe9.7.2025 10:02:00 CEST | Press release
Inspired by the FreeForm 2.0 philosophy, this revolutionary open-frame chassis is now available across Europe at an MSRP of €199 Cooler Master, a global leader in PC hardware and innovative thermal solutions, today announced the European sales kick-off of the MasterFrame 600, a high-end, modular open-frame full tower designed for power users, creators, and PC modders seeking total creative freedom and high-performance potential. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250709203901/en/ Cooler Master's MasterFrame 600 is built on our FreeForm 2.0 philosophy offering owners more customization options for personal builds. The MasterFrame 600 is available across Europe at a suggested retail price of €199, exclusively through select partners and resellers. Engineered on Cooler Master’s FreeForm 2.0 platform, the MasterFrame 600 redefines what’s possible in a premium PC chassis. This open-frame full tower delivers exceptiona
Kaneka Obtains Halal Certificate for KANEKA UBIQUINOL TM9.7.2025 03:30:00 CEST | Press release
Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO:4118) has obtained “Halal Certificate (Certification Number: 355-TSRI/24)” for its functional food ingredient, KANEKA UBIQUINOLTM (active form of coenzyme Q10) powder, under the assessment of Shariah Research Institute of Takushoku University, and issued by JAPAN MUSLIM ASSOCIATION, a religious corporation, on May 28. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708279133/en/ Halal certificate Halal certification is a system in which relevant organizations verify that products or services do not contain ingredients prohibited under Shariah (Islamic law) and certify their compliance with Shariah. We actively pursue the acquisition of various certifications to ensure the safety and security of our raw materials, and we are pleased to announce that we have obtained a Halal Certificate for KANEKA UBIQUINOLTM. Currently, the Muslim populati
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