Incyte (Nasdaq:NASDAQ: INCY ) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
“The positive CHMP opinion brings us one step closer to bringing ruxolitinib cream, the first ever treatment for repigmentation in non-segmental vitiligo, to patients and healthcare professionals in the European Union (EU),” said Steven Stein, M.D., Chief Medical Officer, Chief Medical Officer, Incyte. “With no centrally approved treatment option currently available in the EU, this positive opinion marks a significant milestone for the vitiligo community.”
The CHMP opinion recommending the approval of ruxolitinib cream was based on data from two pivotal Phase 3 clinical trials (TRuE-V1 and TRuE-V2) evaluating the safety and efficacy of ruxolitinib cream versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older1. Results from the TRuE-V program, recently published in The New England Journal of Medicine, showed that treatment with ruxolitinib cream 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, with a higher proportion of patients responding at Week 521. The most common adverse reactions (incidence ≥ 1%) were application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia2.
The CHMP’s opinion is now being reviewed by the European Commission, which has the authority to grant centralized marketing authorizations for medicinal products in the EU. When approved, this will be the first approved vitiligo therapy available in the EU indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
“Given its complex pathogenesis and unpredictable progression, vitiligo can be very challenging for dermatologists to treat,” said Thierry Passeron M.D., Ph.D., Professor and Chair, Department of Dermatology, Université Côte d'Azur in Nice, France and one of the lead investigators of the TRUE-V trials. “I welcome today’s news and look forward to the potential approval of an effective therapy that can address repigmentation, providing a much-needed option for those patients living with vitiligo who are actively seeking treatment, as well as the clinical community dedicated to its treatment.”
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. Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo. In Europe, approximately 1.5 million patients are diagnosed with vitiligo (0.2 to 0.8% of the population3,4), and its overall prevalence is estimated to be less than 1%, with the majority of patients (approximately 8 in 10) suffering from non-segmental vitiligo5. Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 306. Vitiligo not only impacts physical health but also places a heavy burden on quality of life including employment and psychosocial health such as depression.
The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo. Each study enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo.
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