The European Medicines Agency (EMA) has recommended that ruxolitinib cream (Opzelura), developed by the pharmaceutical company Incyte, be approved as the first treatment for non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, based on in the 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 Drug Agency) for the repigmentation of this type of vitiligo.
Vitiligo is a chronic autoimmune disease that causes the destruction of melanocytes – which are the cells that produce melanin – in the epidermis, which leads 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 influences the patient’s social relationships and work activity and can trigger problems, such as depression or social phobia.
It is estimated that in Europe there are around 1.5 million people diagnosed with vitiligo (between 0.2% and 0.8% of the population), and that the prevalence of the disease globally is less than 1%. . The majority of patients (approximately 85%) suffer from non-segmental vitiligo, for which no drug is available in Europe, so Opzelura can fill this need.
“As there is currently no centrally approved treatment option in the EU, this positive opinion 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, the company’s chief medical officer. “As there are currently no centrally approved treatment options in the EU, this positive opinion marks an important milestone for the vitiligo patient community.”
Opzelura has been tested in more than 600 vitiligo patients
Ruxolitinib cream has been tested in two pivotal phase III clinical trials (TRuE-V1 and TRuE-V2) in which the safety and efficacy of the drug was analyzed by comparing it with another product of similar appearance (cream without active substance) in more than 600 patients with non-segmental vitiligo older than 12 years.
Results from the TRuE-V program have been published in The New England Journal of Medicine and show that treatment with ruxolitinib cream produced significant improvements in facial and total body repigmentation compared to the other product, as demonstrated by the number of patients receiving at week 24 achieved study target Total Body and Facial Vitiligo Area Score Index (F-VASI-T-VASI) endpoints compared to vehicle, with a higher proportion of patients responding at week 24 week 521.
The most frequently observed adverse effects in those treated with ruxolitinib (with an incidence ≥ 1%) were acne or pruritus in the area of application of the cream, nasopharyngitis, headache, urinary tract infection, erythema at the site of application and pyrexia.
The European Commission is in charge of granting marketing authorizations for medicines throughout the European Union and is now reviewing the positive opinion of the CHMP. 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 of age.
“Given its complex pathogenesis and its unpredictable course, the treatment of vitiligo can be a great challenge for dermatologists,” said Thierry Passeron, director of the Department of Dermatology at the Côte d’Azur University in Nice (France) and one of the principal investigators of the TRUE-V trials. “I look forward to the approval of an effective treatment to treat repigmentation, which will provide a much-needed option for vitiligo patients who are actively seeking treatment, as well as the clinical community dedicated to their treatment,” he concludes.
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