FDA approves new cream to treat vitiligo

Until now, no treatment has been approved to “repigment” patients with vitiligo, a chronic autoimmune disease that affects more than a million people in France. But the Food and Drug Administration has just approved the marketing of the treatment Ruxolitinib in the United States. An announcement that raises real hope on the other side of the Atlantic.

Ruxolitinib to treat this incurable skin disease

For several months, everyone had been waiting for him. This cream – “Opzelura” – is the first vitiligo treatment to be approved in the USA. Its Ruxolitinib concentration is 1.5%. It is also the only topical formulation of a JAK (Janus kinase) inhibitor.

Manufactured by the American pharmaceutical company Incyte, the drug is intended for all patients over the age of 12 (adults and children) and suffering from non-segmental vitiligo, a very localized form of the disease.

Before being marketed, it was the subject of numerous tests. In 2019, for example, a large study had already shown the positive effects of the drug on the white spots of patients.

Topical ruxolitinib: a long-lasting treatment

Today, the drug is approved for continuous topical use 2 times a day on the affected areas, on a limited body surface (up to 10%).

Be careful, however, not to consider this drug for a miracle treatment: the body’s response to “topical ruxolitinib” may be long overdue. It is therefore sometimes necessary to follow the treatment for more than 24 weeks before obtaining a response from the body.

Dr. Rosmarin, principal investigator of the phase 3 clinical trials of topical ruxolitinib, specifies in this regard that “continued use of the drug beyond six months and beyond one year also leads to continued benefit”, before adding that “ruxolitinib cream as monotherapy is effective in repigmenting both the face and the whole body in adolescents, as well as in adults”.

It remains to be seen now when the drug will land on the European market.