Opzelura cream, the first treatment for vitiligo, is now authorized and reimbursed in France.
- The first treatment for vitiligo is authorized in France thanks to the direct access system.
- The cream which repigments the skin is a treatment reserved for patients over 12 years old.
- It is reimbursed by Health Insurance.
Patients suffering from vitiligo now have a solution to combat depigmentation of their skin. Cream Opzeluradeveloped by the American laboratory Incyte Biosciences, was authorized by a decree published in the Official Journal, published on January 31, 2024. It will also be reimbursed by Health Insurance.
Vitiligo: a first treatment available and reimbursed in France
Nine months later having obtained the green light from the European Medicines Agency, the cream against vitiligo is authorized on French soil thanks to the direct access system. The latter gives patients access to “innovative” treatments without waiting for the finalization of all the formalities allowing official access to the market such as price negotiation. In addition, it provides for a “100% supported by theHealth Insurance for a maximum period of one year, upon publication of the opinion of the Transparency Commission (CT) of the High Authority of Health (HAS)“.
Questioned by AFP, the spokesperson in France for the manufacturer ofOpzeluraClear Lhériteau-Calmé, specifies that the cream treats “non-segmental vitiligo with facial involvement in adults and adolescents over 12 years old”.
The product, distributed by hospital pharmacies, must be applied twice a day. By following this dosage, “the patient will see himself repigment gradually”she adds, recalling that a phase III study had established an improvement in the face after six months of treatment for approximately 31% of patients.
This anti-vitiligo treatment is already available in the United States, Germany and Austria.
Vitiligo: what is this ?
Vitiligo is an autoimmune disease that is characterized by depigmentation of the skin. White spots can thus appear on different areas of the body such as the face, hands, feet or back. Depigmented patches are mostly painless, but they are likely to cause itching.
“Although it is considered a benign disease, vitiligo is not trivial: it has significant psychological repercussions, which can significantly alter the quality of life of people who suffer from it.”reminds himInserm.
The causes of vitiligo are still poorly identified. However, studies have shown that there is a hereditary component. Have a parent of 1er Affected degree of this dermatological disorder carries a 5-8% risk of also developing the disease.
Pathology can occur at any age. Between 0.5 to 1% of the world population in sufferregardless of gender, skin type or color.
