After the United States, Europe. The European Medicines Agency issued a marketing authorization at the end of April for a medicine in the form of a cream, which has shown its effectiveness in the repigmentation of skin affected by non-segmental vitiligo.
Models displaying their depigmented skin on the catwalks and social networks, ex-Prime Minister openly evoking the subject on TV sets… Long taboo, vitiligo, a benign skin disease with often significant psychological repercussions, has come out of the shadows for some time. years.
Until now, the reference treatments for this disease of autoimmune origin with genetic predisposition were based on “Narrow-spectrum UVB rays and topical corticosteroids (cortisone cream)” for localized and generalized vitiligo (also called non-segmentary), indicates the French Society of Dermatology. In some cases, the transplant of melanocytes, these cells responsible for the coloring of the skin which disappear in vitiligo, can be considered.
Ruxolitinib
But the situation could soon change, at least for people with non-segmental vitiligo, which causes bilateral and symmetrical lesions. Less than a year after the Food and drug administration (FDA), the European Medicines Agency has in turn given the green light to the marketing in the European Union of Opzelura, a drug developed by the American laboratory Incyte.
Its main active substance, ruxolitinib, “works by blocking enzymes known as Janus kinase (JAK) 1 and 2, which are involved in the activity of a substance called interferon gamma (IFNγ)”describes the European Medicines Agency. “In patients with vitiligo, IFNγ is thought to play a role in the activity of immune system cells that attack melanocytes. By blocking JAK1 and JAK2, ruxolitinib reduces the ability of the immune system to destroy melanocytes, which allows them to produce pigments.”
Face included
Concretely, Opzelura comes in the form of a cream to be applied to depigmented skin twice a day, face included, but “should not be applied to more than 10% of the body at a time”. Initiated and monitored by a doctor, the treatment “may be required for more than six months in order to achieve repigmentation satisfactory for the skin”. When it will be available in France, it will only be issued on prescription, for adults and adolescents over 12 years old.
Main adverse effect associated with the application of Opzelura: the appearance of acne on the application site, indicates the European Medicines Agency. Who therefore believes that the risk-benefit balance of the treatment is largely favorable to it: two studies carried out on more than 600 people with non-segmental vitiligo have shown that “approximately 31% of patients who received Opzelura achieved at least a 75% improvement in their facial pigmentation after six months of treatment”. And on the body, this pigmentation improved by at least 50% in 22% of patients.
To note : Very active in informing and supporting people affected, the French Vitiligo Association hopes that Opzelura will actually be available in the coming months in pharmacies in the territory. We do not yet know, to date, the conditions for a possible reimbursement by Medicare.