Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with vitiligo and atopic dermatitis (AD) will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, held virtually from September 29-October 2, 2021.
The 24-week data from the Phase 3 TRuE-V program evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo will be presented as a late-breaking oral presentation. Incyte previously announced that both the TRuE-V1 and TRuE-V2 studies met the primary and key secondary endpoints.
“We look forward to sharing data demonstrating the potential of ruxolitinib cream as an effective treatment option for patients living with vitiligo with the dermatology community at this year’s EADV virtual congress,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “These data from the Phase 3 TRuE-V program underscore our commitment to bringing new therapies to patients with challenging skin diseases.”
Key abstracts include:
Late-Breaking Oral Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: 24-Week Results From 2 Randomized, Double-Blind Phase 3 Studies (Abstract #D3T01.2A. Session: Late Breaking News. Saturday, October 2, 5:15-6:15 a.m. ET)
Oral Presentation
Atopic Dermatitis
Efficacy and Safety of Ruxolitinib Cream among Patients Aged ≥65 Years with Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #FC01.01. Session: Atopic dermatitis/Eczema. Thursday, September 30, 4:00-4:10 a.m. ET)
Poster Presentations
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Baseline Clinical Characteristics (encore) (Abstract #P0187. Session: Atopic dermatitis/Eczema)
Efficacy of Ruxolitinib Cream among Patients with Atopic Dermatitis Based on Previous Medication History (encore) (Abstract #P0192. Session: Atopic dermatitis/Eczema)
Effects of Ruxolitinib Cream in Patients with Atopic Dermatitis with Baseline Body Surface Area ≥10% and Eczema Area and Severity Index Score ≥16 (encore) (Abstract #P0190. Session: Atopic dermatitis/Eczema)
Patient-Reported Outcomes of Ruxolitinib Cream for the Treatment of Atopic Dermatitis (encore) (Abstract #P0188. Session: Atopic dermatitis/Eczema)
More information regarding the virtual conference is available on the EADV website: https://www.eadvcongress2021.org/. Following the conference, all e-Posters will be made available online on http://www.eadv.org for EADV members.
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.
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 atopic dermatitis, 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 Incyte’s TRuE-V clinical program, whether and when ruxolitinib cream might be approved to treat patients with vitiligo or atopic dermatitis (AD), the potential for success of such treatment, 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 U.S. FDA and other regulatory authorities outside of the United States; 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 June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210913005816/en/
Contact information
Media
Catalina Loveman
+1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci
+1 302 498 7036
jantonacci@incyte.com
Investors
Christine Chiou
+1 302 274 4773
cchiou@incyte.com
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
NHOA Energy Achieves Great Place To Work Certification in Italy, the United States and Australia18.12.2025 10:53:00 CET | Press Release
NHOA Energy, global provider of utility-scale energy storage systems, announces that it has been certified Great Place To Work® in Italy, the United States, and Australia. The certification is based entirely on direct feedback from NHOA Energy employees, gathered through an independent and structured listening process. Great Place To Work® Certification™ assesses the quality of the employee experience across key dimensions such as credibility, respect, fairness, pride, and camaraderie. The results achieved by NHOA Energy reflect a corporate culture built on trust, inclusion, and the consistent commitment to valuing people within a dynamic and international environment. Employees highlighted particularly high levels of appreciation for the ethical and transparent behavior of leaders, the welcoming and inclusive approach toward new hires, and fair treatment across diversity, equity, and inclusion dimensions. A strong majority also expressed pride in working at NHOA Energy and reported a
Regnology Signs an Agreement to Acquire Moody’s Regulatory Reporting & ALM Solutions18.12.2025 10:00:00 CET | Press Release
Regnology, a leading provider in regulatory, risk, tax, and finance reporting, as well as supervisory technology, today announced it has signed an exclusive agreement for the acquisition of Moody’s Regulatory Reporting & ALM Solutions business, inclusive of solutions for Basel III compliance, IFRS9 impairment accounting, large bank asset-liability management (ALM), Solvency II insurance reporting, and prudential and statistical regulatory reporting across more than 50 jurisdictions. By integrating Moody’s regulatory capital and liquidity capabilities with Regnology’s regulatory, risk, and finance offerings, the firm is creating a unified, scalable platform designed to meet the full spectrum of financial regulatory compliance and risk requirements. This combined strength positions Regnology as the partner of choice for financial institutions seeking future-ready solutions. At the core of this strategy is Regnology Risk Hub (RRiskHub), an integrated solution designed to deliver a single
Reply Recognized as a Microsoft Azure Expert Managed Services Provider for the Sixth Consecutive Year18.12.2025 10:00:00 CET | Press Release
Reply [EXM, STAR: REY] announced today it has been recognized once again as a Microsoft Azure Expert Managed Services Provider (MSP). The renewal reaffirms Reply’s proven expertise and consistent track record in delivering high-quality cloud solutions and services on the Microsoft Azure platform, powered by the deep technical expertise of its specialized companies – Cluster Reply, Solidsoft Reply and Valorem Reply. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218596617/en/ This recognition reflects the ongoing collaboration between Reply - through its companies Cluster Reply, Solidsoft Reply, and Valorem Reply - and Microsoft, supporting shared efforts to deliver value-driven services to enterprise customers. The Azure Expert MSP program is designed by Microsoft to identify and validate partners with proven capabilities in delivering end-to-end Azure services at scale. To qualify, partners must meet a strict set of requ
Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment18.12.2025 09:00:00 CET | Press Release
Takeda(TSE:4502/NYSE:TAK)today announced positive topline results for the two pivotal Phase 3randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). The studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75, at week 16, with a significantly greater PASI 75 response rate seen as early as week 4 and continuing to increase through week 24. The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, showing the potential of a convenient once-daily pill to deliver complete skin clearance for patients with PsO. “People living with psoriasis continue to seek safe, effective and fast-acting oral therap
DATROWAY ® Type II Variation Application Validated in the EU as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who are Not Candidates for Immunotherapy18.12.2025 08:30:00 CET | Press Release
The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from the TROPION-Breast02 phase 3 trial presented in a late-breaking proffered paper session at the 2025 European Society for Medical Oncology (#ESMO25) Congress. In the trial, DATROWAY demonstrated statistically significant and clinical
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