It is a ray of hope for people with vitiligo, this disease which causes progressive depigmentation of the epidermis and hair system and is characterized by white spots on the face, feet, hands, or any other Part of the body.
On April 20, the European Commission gave its approval to the marketing in Europe of Opzelura (ruxolitinib), a cream developed by the Incyte laboratory. A first. The drug has already been authorized in the United States since July 2022. In Europe, Germany will most likely be the first country to market it. In France, given the time during which the High Authority for Health assesses the drug with a view to its reimbursement by Medicare and the setting of its price, Opzelura is expected for the first quarter of 2024.
This chronic autoimmune disease, linked to the loss of melanocytes which normally synthesize melanin, the main coloring pigment of the skin, affects between 0.5% and 2% of the world’s population, 50% of patients developing this pathology before age. 20 years old. 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.
“Sick people in great pain”
In daily life, vitiligo can have a major impact on those affected, both in their professional life and in their social and emotional relationships. And the weight of this pathology is underestimated. “We too often hear ‘it’s psychological, we can’t do anything’ or ‘it’s aesthetic, it’s not very bad’, but we know that it’s an autoimmune disease that has genes in common with alopecia areata, type 1 diabetes, lupus or even thyroid problemsunderlines Thierry Passeron, head of the department of dermatology of the CHU of Nice. Certainly, in recent years, personalities, such as the Canadian model Winnie Harlow, have made it an asset, but, unfortunately, the vast majority of patients are in real pain. »
To make its decision, the European Commission relied on data from two phase 3 clinical trials conducted in the United States and Europe, double-blind, on 674 patients aged 12 and over, suffering from vitiligo. non-segmental (affecting the body bilaterally and fairly symmetrically), with depigmentation covering 10% or less of the total body surface area. In France, the three reference centers – Bordeaux, Nice and Créteil University Hospitals – took part in these trials. The results were published in the New England Journal of Medicine, in October 2022. In detail, patients applied the cream or a placebo twice a day for 24 weeks to all areas of vitiligo, face or body. Specifically, the active substance in ruxolitinib blocks enzymes known as Janus kinases (JAK 1 and 2) and reduces the ability of the immune system to attack melanocytes.
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