European Commission approves ruxolitinib for the treatment of non-segmental vitiligo with facial involvement

Ruxolitinib cream is the first treatment approved in the European Union for repigmentation in non-segmental vitiligo. The European Commission’s decision is based on data from two pivotal Phase 3 clinical trials – TRuE-V1 and TRuE-V2 – that evaluated the efficacy and safety of ruxolitinib cream in more than 600 people with non-segmental vitiligo, aged aged 12 or over.

26 APR – The European Commission has granted a marketing authorization for Incyte’s ruxolitinib cream 15 mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents aged 12 years and older.

Ruxolitinib cream – to be sold under the trade name Opzelura – is the first and only approved treatment in the European Union to offer repigmentation support in eligible patients with non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of the skin and reduced quality of life.

The EC decision follows the positive opinion received in early 2023 from EMA’s Committee for Medicinal Products for Human Use (CHMP) and is applicable to all 27 EU Member States, Iceland, Norway and to Liechtenstein.

“The approval of ruxolitinib cream by the European Commission represents significant progress for people living with non-segmental vitiligo with facial involvement who, until now, have had no approved medical treatment to induce repigmentation,” he notes. Hervé Hoppenot, CEO of Incyte. “This approval would not have been possible without the support of Vitiligo patients and the medical community and without the efforts of our research and development teams. We will now work in individual European countries to bring this long-awaited therapy to eligible patients seeking to treat their Vitiligo.”

The European Commission’s decision is based on data from two pivotal Phase 3 clinical trials – TRuE-V1 and TRuE-V2 – which evaluated the efficacy and safety of ruxolitinib cream versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, 12 years of age and older.

Results from the TRuE-V program demonstrated that treatment with ruxolitinib cream resulted in significant improvements in full-body and facial repigmentation compared to vehicle, as demonstrated by the number of patients meeting the area score index endpoints of facial and total body Vitiligo Area Scoring Index (F-VESSELS and T-VESSELS) at week 24 versus vehicle and, in an open-label extension, at week 52.

Results at week 24, consistent across both studies, showed that 29.8% and 30.9% of patients treated with ruxolitinib cream achieved at least a 75% improvement from baseline in the score index. area of ​​facial vitiligo (F-VASI75), the primary endpoint, compared with 7.4% and 11.4% of vehicle-treated patients in TRuE-V1 and TRuE-V2, respectively. At week 52, approximately one in two of patients treated with ruxolitinib cream achieved F-VASI75 response.

In addition, at week 24, more than 15% of patients treated with ruxolitinib cream achieved a ≥90% improvement from baseline in F-VASI score (F-VASI90) compared with approximately 2% of patients treated with vehicle. At week 52, approximately one in 3 patients treated with ruxolitinib cream achieved an F-VASI90 response.

There were no serious adverse events related to treatment with ruxolitinib cream, and the most common adverse reaction was application site acne.

Data from the pivotal Phase III trials supporting the European Commission’s decision were also published by The New England Journal of Medicine.

“The approval of ruxolitinib cream is good news for dermatologists and eligible patients in Europe who often face challenges in managing vitiligo,” he says Markus Boehm, Department of Dermatology, University of Münster, Germany. “TRuE-V is the first large-scale clinical trial program for Vitiligo and its results clearly demonstrate the clinically meaningful improvements in total body and facial repigmentation seen with ruxolitinib cream and its potential to further optimize care and patient outcomes. .”

Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin which results in a patchy loss of skin color following the progressive destruction of pigment-producing cells, known as melanocytes. Overactivity of the JAK signaling pathway is thought to drive inflammation involved in the pathogenesis and progression of vitiligo.

In the European Union, EEA countries and the United Kingdom, the prevalence of diagnosed vitiligo is estimated to be approximately 1.5 million patients of which approximately 8 in 10 suffer from non-segmental vitiligo, and a subset of these have involvement of the face and requires treatment. Vitiligo can occur at any age, although many patients with Vitiligo first experience symptoms before the age of 30.

“Vitiligo is a chronic autoimmune disease that impacts many aspects of a person’s life,” he concludes Jean Marie Meurant, Vice-President of the International Committee of Vitiligo Patients’ Organizations (VIPOC). “The arrival of new treatment options is important to our community, because it gives people affected by Vitiligo what they have long hoped for: the ability to choose to treat their condition.”

April 26, 2023
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