The European Medicines Agency (EMA) has recommended a drug developed by the pharmaceutical company Incyte (Opzelura) as a first-line treatment for non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP). This product is the first and only one approved by the FDA (American Medicines Agency) for the repigmentation of this type of vitiligo.
Vitiligo is a chronic autoimmune disease that causes the destruction of melanocytes, which are melanin-producing cells in the epidermis, leading to progressive depigmentation of the skin, in which lighter colored spots appear. This disorder affects people of any age, but in many cases it appears before the age of 30, which is why it affects social relationships and work activity and can trigger problems such as depression or social phobia.
It is estimated that in Europe around 1.5 million people are diagnosed with vitiligo (between 0.2% and 0.8% of the population), and the global prevalence of the disease is less than 1%. Most of the patients (about 85%) suffer from non-segmental vitiligo, for which there is no drug available in Europe, so Opzelura can fill this need.
“Although there is no centrally approved treatment option in the EU, this positive decision marks an important milestone for the vitiligo patient community.”
“The positive opinion from the CHMP brings us one step closer to making ruxolitinib cream, the first treatment for repigmentation of non-segmental vitiligo, available to patients and healthcare professionals in the European Union (EU),” said Steven. Stein, a company company. chief medical officer “Although there are no centrally approved treatment options in the EU, this positive decision marks an important milestone for the vitiligo patient community.”
Opzelura has been tested on more than 600 vitiligo patients
Ruxolitinib cream has been tested in two pivotal, III clinical trials (TRuE-V1 and TRuE-V2), in which the safety and efficacy of the drug are analyzed, comparing it with another product of a similar type (a cream without the active substance) in more than 600 patients with non-vitiligo a stallion older than 12 years.
The results from the TRuE-V program were published in The New England Journal of Medicine and show that treatment with ruxolitinib cream has significant improvements in facial and total body repigmentation compared to the other product, as demonstrated by the number of patients receiving it at week 24. performed a target study Total Body and Facial Vitiligo Area Score Index (F-VASI-T-VASI) compared to the vehicle, with a higher proportion of patients responding at week 24 of week 521.
The most frequently observed adverse effects in those with ruxolitinib (with an incidence of ≥ 1%) were acne or pruritus in the area of ​​cream application, nasopharyngitis, headache, urinary tract infection, erythema at the application site, and pyrexia. .
The European Commission is in charge of granting marketing authorizations for medicines throughout the European Union and is currently reviewing the CHMP’s positive opinion. If finally approved, Opzelura will become the first treatment available in the EU for non-segmental vitiligo with facial involvement in adults and adolescents from 12 years.
“Given the complex pathogenesis and the unpredictable course, the treatment of vitiligo is a great challenge for dermatologists,” said Thierry Passeron, director of the Department of Dermatology at the University of the Cote d’Azur in Nice (France) and one of the principals. investigators of the judgments of truth-v. “I look forward to the approval of an effective treatment to treat repigmentation, which will provide a much-needed option for vitiligo patients who seek active treatments, as well as a clinical community dedicated to their treatment,” he concludes.
