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
Thales Builds Cryptographic Security for the Age of AI and Post-Quantum Computing14.9.2026 09:00:00 CEST | Press release
Thales launches Luna 8, a new hardware security module (HSM) to provide future-ready, quantum resistant security to protect critical data and applications Powered by a Thales designed cryptographic processor, it delivers unparalleled performance, enhanced protection and the flexibility to adapt to new security needs Drawing on decades of cryptographic expertise, Luna 8 combines trusted security with support for emerging technologies, including post quantum cryptography According to the 2026 Thales Data Threat Report, the threat of Harvest Now, Decrypt Later (HNDL) attacks was the top-cited risk, with 59% of organizations reporting that they are prototyping and evaluating post-quantum cryptography (PQC) algorithms to prepare for the quantum era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804748922/en/ ©Thales To help organizations turn this readiness into deployment,Thales, a global leader in advanced technologies, tod
U.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s Zasocitinib in Moderate-to-Severe Plaque Psoriasis, with Potential to Redefine Oral Treatment Expectations14.9.2026 09:00:00 CEST | Press release
Acceptance is based on pivotal Phase 3 data demonstrating rapid, durable and consistent skin clearance, including in high-impact sites, in a convenient once-daily pill Results from nearly 3,000 patients support potential for next-generation TYK2 inhibitor to redefine oral treatment expectations in psoriasis The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027 Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis. Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable and consistent skin clearance in Phase 3 plaque psoriasis studies.1-3 Addressing unmet needs in psoriasis treatment “Despite progress in psoriasis care, there remains a need for highly
SWISSto12 and Mitsubishi Electric Corporation Announce Strategic Partnership14.9.2026 09:00:00 CEST | Press release
The Memorandum of Understanding (MoU) and additional contract signal a new phase of collaboration on market development in the Asia Pacific (APAC) region SWISSto12 today announced a memorandum of understanding (MoU) with Mitsubishi Electric Corporation (MELCO) (TOKYO: 6503) to pursue joint opportunities on advanced payloads, radio frequency (RF) products, and market development in Japan and the APAC region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914982179/en/ Masahiko Arai, Executive Officer and Group President, Defense & Space Systems, Mitsubishi Electric, and Dr. Emile de Rijk, Chief Executive Officer, SWISSto12 Joint opportunities will leverage MELCO’s extensive satellite system expertise and integration capabilities together with SWISSto12’s proprietary 3D-printing designs and processes that form the foundation of its next-generation payloads—smaller, lighter, highly performant, yet built in materially shorter
Focused Support Launches Cavok STRIKE to Expand Link-16 Participation Across the Joint Force14.9.2026 07:00:00 CEST | Press release
Extending Link-16 interoperability without platform-level hardware integration Focused Support LLC today announced the launch of Cavok STRIKE, an integrated software capability that expands the Link-16 tactical battlespace picture by enabling additional operational platforms to participate in the Link-16 network. Modern battlefields have increasing numbers of unmanned systems, sensors, and supporting platforms operating throughout the joint battlespace. The rapid proliferation of Group 1, 2, and 3 UAS, including both expendable and recoverable systems, has created a growing need to integrate these assets into the broader tactical network. Many of these platforms provide operationally relevant information but have historically remained outside the Link-16 network due to limitations in size, weight, power, platform integration complexity, or acquisition cost. Cavok STRIKE addresses this gap by enabling platforms to participate in the Link-16 network as non-command-and-control participant
Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma14.9.2026 07:00:00 CEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil. “ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.” The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two
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