This is a ray of hope for people with vitiligo, a disease that causes progressive depigmentation of the skin and hair and is characterized by white patches on the face, feet, hands, or any other part of the body.
On April 20, the European Commission granted market authorization in Europe for Opzelura (ruxolitinib), a cream developed by the Incyte laboratory – a drug that had been approved in the United States in July 2022. In Europe, Germany will most likely be the first country to market it. In France, given the delays while the French National Authority for Health evaluates the drug for reimbursement by Medicare and sets its price, Opzelura is expected to be available in the first quarter of 2024.
This chronic autoimmune disease, linked to the loss of melanocytes that normally synthesize melanin, the main pigment that colors the skin, affects between 0.5% and 2% of the world’s population, with 50% of patients developing the condition before 20. In France, it is estimated that between 600,000 and 1 million people suffer from it. Men are as affected as women, and regardless of skin color.
‘Patients suffer greatly’
Vitiligo can have a major impact on its victims’ daily life, both in their professional life and in their social and emotional relationships. And the weight of this pathology is underestimated. “We often hear ‘it’s psychological, we can’t do anything about it’ or ‘it’s aesthetic, it’s not really bad,’ but we know that it is an autoimmune disease that has genes in common with alopecia, type 1 diabetes, lupus or even thyroid problems,” stressed Thierry Passeron, head of the dermatology department of Nice university hospital. “It’s true that in recent years, celebrities such as Canadian model Winnie Harlow have made it an asset, but unfortunately, the vast majority of patients are really suffering.”
In making its decision, the European Commission relied on data from two double-blind Phase 3 clinical trials conducted in the United States and Europe on 674 patients aged 12 and older, suffering from non-segmental vitiligo (which affects the body bilaterally and fairly symmetrically ), with depigmentation covering 10% or less of the total body surface. In France, the three reference centers – Bordeaux, Nice, and Créteil university hospital – participated in these trials. The results were published in the New England Journal of Medicine in October 2022. Specifically, patients applied the cream or a placebo twice a day for 24 weeks to all areas of vitiligo on the face or body. The active substance in ruxolitinib blocks the enzymes known as Janus kinases (JAK 1 and 2) and reduces the immune system’s ability to attack melanocytes.
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