DE-INCYTE
29.9.2023 19:44:31 CEST | Business Wire | Press release
Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin.
“We are pleased to add to the data supporting the use of ruxolitinib cream for patients living with vitiligo and atopic dermatitis (AD) through two late-breaking presentations – one on prolonged use of treatment in vitiligo patients with limited or no initial response, and the full results of our TRuE-AD3 trial in pediatric AD,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Collectively, the data at this year's Congress, which also include new late-breaking data for povorcitinib in vitiligo, emphasize our ongoing efforts to advance treatment options for the Dermatology community."
Key abstracts from Incyte-sponsored programs include:
Late-breaking Oral Presentations
Vitiligo
Efficacy and Safety of Povorcitinib for Extensive Vitiligo: 52-Week Results from a Double-Blinded, Placebo-Controlled, Dose-Ranging Phase 2b Study (Abstract #6749. Session: D1T01.1A: Late Breaking News. Wednesday, October 11, 8:15 a.m. – 8:30 a.m. ET)
Efficacy of Prolonged Ruxolitinib Cream Treatment for Vitiligo Among Patients with Limited or No Initial Response at 6 Months (Abstract #6479. Session: D1T01.1I: Late Breaking News. Wednesday, October 11, 10:30 a.m. – 10:45 a.m. ET)
Atopic Dermatitis (AD)
A Phase 3 Study of Ruxolitinib Cream in Children Aged 2–<12 Years with Atopic Dermatitis (TRuE-AD3): 8-Week Analysis (Abstract #6746. Session: D3T01.3I: Late Breaking News. Friday, October 13, 10:30 a.m. – 10:45 a.m. ET)
Oral Presentations
Hidradenitis Suppurativa
Baseline Demographic and Disease Characteristics Associated with Achieving HiSCR with Povorcitinib: Secondary Analysis from a Phase 2, Randomized, Placebo-Controlled Clinical Trial (Abstract #2803. Session: FC02.1: Free Communications II. Thursday, October 12, 4:15 a.m. – 4:25 a.m. ET)
Impact of Povorcitinib on DLQI and DLQI Subdomains in Patients with Hidradenitis Suppurativa: Results from a Randomized, Placebo-Controlled Phase 2 Study (Abstract #2795. Session: FC02.2: Free Communications II. Thursday, October 12, 4:25 a.m. – 4:35 a.m. ET)
ePosters
Vitiligo
Effect of Ruxolitinib Cream on VASI-50 Achievement by Body Region Through Week 104 in Patients with Vitiligo: Analysis of the TRuE-V Long-Term Extension Phase 3 Study (Abstract #926)
Efficacy and Safety of Ruxolitinib Cream Through Week 104 in Patients with Vitiligo: Subgroup Analysis of the TRuE-V Long-Term Extension Phase 3 Study (Abstract #927)
Characterization and Treatment of Acne that Occurred Among Individuals with Vitiligo who Applied Ruxolitinib Cream in Two Randomized Phase 3 Trials (Abstract #2595)
Depression and Depressive Symptoms Among Persons Living with Vitiligo: Findings from the Global VALIANT Survey (Abstract #2572)
Treatment Satisfaction, Breaks and Cessation Among Patients Living with Vitiligo: Findings from the Global VALIANT Survey (Abstract #2579)
Retrospective Database Analysis on the Treatment Patterns in Patients with Vitiligo in Quebec, Canada (Abstract #2591)
Epidemiology and Comorbidity of Patients with Vitiligo in Germany (Abstract #3072)
AD
A Maximum-Use Trial of Ruxolitinib Cream in Children Aged ≥2 years to <12 Years with Atopic Dermatitis: 8-Week Analysis (Abstract #2551)
Rapid, Substantial and Sustained Reduction of Itch in Adults with Atopic Dermatitis Applying Ruxolitinib Cream — Clinical and Translational Results from the Open-Label Phase 2 SCRATCH-AD Study (Abstract #2813)
For full session details and data presentation listings, please see the EADV Congress 2023 (https://eadvcongress2023.org/scientific/) online program.
About Opzelura® (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. 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 Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of Incyte.
About Povorcitinib (INCB54707)
Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 2 clinical trials for vitiligo, hidradenitis suppurativa (HS), prurigo nodularis, chronic spontaneous urticaria and asthma. Phase 3 studies in HS are also ongoing.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need.
Our research and development efforts in dermatology are initially focused on leveraging our knowledge of the JAK-STAT pathway. We are exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis.
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 presentation of data from Incyte’s clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte’s goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’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; determinations made by the FDA, EMA and other regulatory authorities; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’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 September 30, 2023. Incyte 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/20230929594890/en/
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
Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release
A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release
Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas
ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release
OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future
Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 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/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority
Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release
Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s
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