Incyte Announces European Commission Approval of Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has granted a marketing authorization for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Opzelura is the first and only approved treatment in the European Union (EU) to offer support for repigmentation in eligible patients with non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin and reduced quality of life.
The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year and is applicable to all 27 European Union Member States, Iceland, Norway and Liechtenstein.
“The approval of Opzelura by the European Commission represents a significant advancement for people living with non-segmental vitiligo with facial involvement who, until now, had no approved medical treatment to address repigmentation,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “This approval wouldn’t have been possible without the support of the vitiligo patient and medical community, and the efforts of our research and development teams. We will now work across individual countries in Europe to bring this much awaited therapy to eligible patients seeking to treat their vitiligo.”
The EC decision is based on data from two pivotal Phase 3 clinical trials (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]), evaluating the efficacy and safety of Opzelura versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older. Results from the TRuE-V program showed that treatment with Opzelura resulted in significant improvements in facial and total body repigmentation versus vehicle as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at Week 24 compared to vehicle and in an open-label extension at Week 521.
Results at Week 24, which were consistent across both studies, showed that 29.8% and 30.9% of patients treated with Opzelura achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively. At Week 52, approximately one in two of Opzelura-treated patients achieved F-VASI751.
Additionally, at Week 24, more than 15% of patients treated with Opzelura achieved ≥90% improvement from baseline in F-VASI (F-VASI90), compared to approximately 2% of patients treated with vehicle. At Week 52, approximately one in three of Opzelura-treated patients achieved F-VASI90.
There were no serious treatment-related adverse events related to ruxolitinib cream and the most common adverse reaction was application site acne1.
Pivotal Phase 3 data supporting the European Commission decision were also published in The New England Journal of Medicine.
“The approval of Opzelura is welcome news for dermatologists and eligible patients in Europe who often face challenges managing vitiligo,” said Prof. Dr. Markus Böhm, Department of Dermatology, University of Münster Germany. “TRuE-V is the first large-scale clinical trials program in vitiligo and its results clearly demonstrate the clinically meaningful improvements in facial and total body repigmentation seen with Opzelura and its potential to further optimize patient care and outcomes.”
Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results in patchy loss of skin color from the progressive destruction of pigment-producing cells known as melanocytes. Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo. In the European Union, EEA countries and UK diagnosed vitiligo prevalence is estimated to be ~1.5 million patients2,3, with approximately 8 in 10 patients suffering from non-segmental vitiligo4, and a subset of whom has facial involvement and seeking treatment. Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 305.
“Vitiligo is a chronic autoimmune disease that impacts many aspects of a person’s life,” said Jean-Marie Meurant, Vice-President of the Vitiligo International Patient Organizations Committee (VIPOC). “The arrival of new treatment options are important for our community as it gives people with vitiligo something they have long been hoping for: the choice to treat their disease.”
About Opzelura® (ruxolitinib) Cream 15mg/g
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 European Union (EU), indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
In patients with non-segmental vitiligo with facial involvement, Opzelura is approved for topical use twice daily to the depigmented skin areas up to a maximum of 10% body surface area. Satisfactory repigmentation may require treatment with Opzelura for more than 24 weeks.
Opzelura is approved in the U.S. for the topical treatment of non-segmental vitiligo in patients 12 years of age and older and 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.
Incyte has worldwide rights for the development and commercialization of Opzelura. In April 2022, Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing, and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan.
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. 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, lichen planus, lichen sclerosus and prurigo nodularis.
To learn more, visit the Dermatology section of Incyte.com.
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.
Except for the historical information set forth herein, the matters set forth in this press release, including statements, regarding whether and when Opzelura will provide a successful treatment option for patients with vitiligo, 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 and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, and other third-party providers and development and discovery operations; determinations made by the European Commission and other regulatory authorities; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners 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 U.S. Securities and Exchange Commission, including its annual report for the year ending December 31, 2022. The Company disclaims any intent or obligation to update these forward-looking statements.
1 Opzelura ® (ruxolitinib) cream 15mg/g. Summary of Product Characteristics (SmPC). Incyte; April 2023.
2 Mohr N, et al. Epidemiology of Vitiligo - A Dual Population-Based Approach. Clinical Epidemiology. 2021 May 26; 13:373-382.
3 Bibeau K, et al. Vitiligo prevalence and quality of life among adults in Europe, Japan and the USA. Journal of the European Academy of Dermatology and Venerology. 2022; V36(10), P 1831-1844.
4 Gandhi K, et al. Prevalence of Vitiligo Among Adults in the United States. JAMA Dermatol. 2022 Jan 1;158(1):43-50.
5 Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and treatment. Annual. Review of Immunology. 2020; 38(1):621-648.
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/20230420005667/en/
+1 302 498 6171
+41 21 343 3113
+1 302 274 4773
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Tezos Foundation and Artist Misan Harriman Unveil First Works in Permanent Art Collection9.6.2023 18:42:00 EEST | Press release
Today, the Tezos Foundation, which promotes development on the Tezos blockchain, and Misan Harriman, the world-renowned photographer and activist, announced the first presentation of the Tezos Foundation Permanent Art Collection to celebrate artists and creators in the Tezos ecosystem. These works will be on display in a Digital Art Gallery, to be revealed on June 16 on the Collection’s website for public viewing. The initial presentation is just a fraction of the overall collection of over 2,000 works acquired between May 2022-2023 with a $1.2M USD endowment from the Tezos Foundation to Misan Harriman. Spearheaded by the Tezos Foundation and driven by Harriman, the initiative reflects the diversity of the digital art community in the Tezos ecosystem and showcases works by artists who span five continents and more than two dozen nationalities. The first online gallery is separated into three rooms - Who We Are, What We Become, and Tracks of Existence - which highlight important themes
Vertex Presents Data Demonstrating Significant Benefits of Long-Term Treatment With CFTR Modulators at the European Cystic Fibrosis Conference9.6.2023 18:00:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 12 scientific abstracts on the company’s portfolio of cystic fibrosis (CF) medicines were presented at this year’s European Cystic Fibrosis Society's (ECFS) 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria. Together, the data presented show the long-term benefits of treatment with CFTR modulators as well as the importance of treating the underlying cause of CF as early in life as possible. Key data presented at this year’s conference are highlighted below. Vertex presented an interim analysis (IA) of a registry-based study of real-world data collected from people with CF and treated with TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, including over 16,000 people with CF from the Cystic Fibrosis Foundation Patient Registry (CFFPR) and nearly 3,00
Galtronics Improves Attendee Experience at NFL Stadiums and MLB Ballparks Nationwide9.6.2023 12:00:00 EEST | Press release
Galtronics, the company that combines collaboration with technology innovation to solve the world’s most complex wireless connectivity challenges, today announced distributed antenna system (DAS) upgrades across four major stadiums. Galtronics’ antennas will be deployed at Arrowhead Stadium, home of the defending Super Bowl Champion Kansas City Chiefs; Ford Field, home of the Detroit Lions; Bank of America Stadium, home of the Carolina Panthers; and T-Mobile Park, home of the Seattle Mariners. The recent upgrades will provide increased sectorization to drive higher levels of capacity and data speeds, allowing fans to stream other sporting events, keep up with fantasy team stats or share live event interaction over social platforms. In total, Galtronics is providing 705 antennas across the three stadiums and ballpark. The C-Band antenna upgrades range from HyperFlat (Ceiling mount Omni DAS Antenna), Small Panel antennas and a combination of 30x30 and 30x60 Stadium Panel Antennas. They w
Superior Graphite to Build 24.000 Ton Per Annum Active Anode Material Capacity at 1/3 the CapEx Cost9.6.2023 11:38:00 EEST | Press release
Superior Graphite, a leading producer of graphite, plans to construct a USD180 million anode materials facility to meet the accelerating demand for EV’s and energy storage in the North American and European markets. The company's state-of-the-art Anode Active Material (AAM) enables and accelerates the energy transition. The main facility will be in Hopkinsville, Kentucky, with additional capacity in Sundsvall, Sweden. Superior Graphite's innovative production technology and established operations at these locations result in a continuous production process, significantly reducing capital requirements and operational costs. "Our technology and product brands are trusted by high-volume customers worldwide. Our unique technology uses approximately 70% less electricity, labor, and space compared to traditional production processes. The carbon footprint is reduced by nearly 85%, and the cost savings for EV companies are substantial," says Ed Carney, CEO of Superior Graphite. Meeting the IRA
Mega Refining and Petrochemical Plant Selects Hytera as Provider of Professional Communications System9.6.2023 11:08:00 EEST | Press release
Hytera, a global leading provider of professional communication technologies and solutions, has been selected as the supplier of professional communications solution for the Yulong Island Refining and Petrochemical Integration Project in Shandong Province, China. Hytera won this public tender with its advanced professional digital trunking (PDT) infrastructure, control and dispatch system , network management system (NMS), digital voice recording system (DVRS), and intrinsically safe (IS) PDT two-way radios . This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230609005125/en/ PD790Ex Intrinsically Safe PDT Two-way Radio (Graphic: Business Wire) The Yulong project is the largest refining and petrochemical facility being constructed in China. With a projected overall production capacity of 40 million tons per year, this plant is a strategic venture aimed at driving economic growth, enhancing energy production capabilities, and pro
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