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
Filippo Fagnani from Quanta System Receives the EAU Award for Significant Contribution to Endourology at ICE 202610.10.2026 18:09:00 CEST | Press release
Filippo Fagnani, Marketing & Scientific Director of Quanta System’s Surgical Division, has been honoured with the Award for Significant Contribution to Endourology at ICE26, the International Conference on Endourology organised by the EAU Endourology Section. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261010101303/en/ Filippo Fagnani receiving the prize with Olivier Traxer and Professor Bhaskar Somani. The recognition celebrates more than two decades of professional commitment to laser technology and a career built around a clear ambition: to translate the needs of urologists into increasingly precise, flexible and useful technologies, with the ultimate goal of supporting patient safety and better surgical outcomes. “I have always believed that technology should make the surgeon’s work more precise, more flexible and, most importantly, safer for the patient. My goal has never been to develop technology for its own sake,
Emdoor Information Marks 18 Years of Rugged Computing Excellence with Vertically Integrated Capabilities10.10.2026 12:30:00 CEST | Press release
As industrial automation, smart manufacturing, and field operations increasingly depend on mission-critical mobile computing, global demand for reliable rugged tablets, rugged laptops, and rugged handhelds continues to accelerate. Emdoor Information, a publicly listed company on China’s A-share main board since 2023 and an 18-year veteran in rugged computing, has established itself as a rugged computing solutions provider for industrial customers worldwide. Founded in 2008, the company delivers sustained growth, world-class manufacturing, resilient supply chains, full-stack R&D, and comprehensive lifecycle services. Its rugged computing products and industrial customers now span North America, Latin America, Europe, and Asia-Pacific, serving sectors such as public utilities, intelligent manufacturing, warehouse management, transportation, energy industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261010564561/en/ Rugged
Vertex to Present New Data on ALYFTREK® at the North American Cystic Fibrosis Conference9.10.2026 19:15:00 CEST | Press release
- Data on ALYFTREK in children ages 2 to 5 years demonstrate recovery of pancreatic function in some children –- Additional abstracts on clinical and real-world evidence on CFTR modulators also presented - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new interim data from the ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor) 2 to 5 years old open-label extension study, highlighting recovery of exocrine pancreatic function in some children in that age group, allowing those children to discontinue pancreatic enzyme replacement therapy (PERT). Pancreatic exocrine insufficiency in children with cystic fibrosis (CF) was previously believed to be irreversible. These data were presented at the North American Cystic Fibrosis Conference (NACFC). “The data presented at NACFC underscore the safety and efficacy of our CF medicines in the real world and in clinical trials in younger age groups. The data from the Phase 3 open-label study in 2 to 5 year olds evaluating exocrine p
Andersen Consulting udvider med TalentSmartEQ for at fremme lederskab og virksomhedstransformation9.10.2026 18:48:00 CEST | Pressemeddelelse
Andersen Consulting styrker sine kompetencer inden for humankapital gennem en samarbejdsaftale med TalentSmartEQ, en San Diego-baseret virksomhed, der har fokus på at skabe praktiske, engagerende og handlingsorienterede læringsoplevelser med udgangspunkt i emotionel intelligens (EQ) og lederudvikling. I mere end to årtier har TalentSmartEQ arbejdet sammen med organisationer verden over med henblik på at udvikle ledelseskompetencer ved hjælp af emotionel intelligens og dermed styrke medarbejderengagement, teamwork og de samlede resultater. Virksomheden kombinerer forskningsbaserede metoder med praktiske læringsforløb, vurderinger, coaching og skræddersyede programmer, der skal omsætte opbygningen af emotionel intelligens til vedvarende ændringer i adfærden på arbejdspladsen. Som førende aktør i branchen samarbejder TalentSmartEQ med organisationer lige fra Fortune 500-virksomheder til offentlige myndigheder og privatejede virksomheder. "Organisationer stiller stadig større krav til dere
Verdant Rock Receives A (low) Financial Strength Rating from Morningstar DBRS, Adding a Second International Investment-Grade Assessment9.10.2026 16:00:00 CEST | Press release
Verdant Rock now holds Financial Strength Ratings from both Fitch Ratings and Morningstar DBRS, providing counterparties with dual-agency confirmation and reinforcing the security architecture behind each financial guarantee Verdant Rock Limited, a Bermuda Monetary Authority-regulated Class 3B insurance company, has received an A (low) Financial Strength Rating from Morningstar DBRS. The rating reflects Verdant Rock’s financial strength and its capacity to meet policyholder obligations as an investment-grade financial guarantor for Emerging Markets credit. Morningstar DBRS is a global credit rating agency with coverage across North America, Europe, Asia, and Latin America. Its assessment of Verdant Rock reflects the company’s strong projected earnings ability, robust risk profile, sound liquidity, and good capitalization. Morningstar DBRS also assigned an A (low) Issuer Rating to Verdant Rock. The rating follows Verdant Rock’s BBB+ Long-Term Insurer Financial Strength Rating with a Sta
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