2024-02-01 08:07:14
Model Winnie Harlow, who suffers from vitiligo, during an interview on February 12, 2015, in New York. JOSHUA LOTT / AFP
“This is big news for patients! We were waiting for this moment with great impatience,” rejoices Martine Carré, president of the French Vitiligo Association. Opzelura, the very first drug developed to treat people suffering from vitiligo, this chronic autoimmune disease which causes progressive depigmentation of the epidermis and hair system, and is characterized by white spots on the face and on the body, is now available in France, according to a decree published in Official newspaperWednesday January 31.
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“Until now, there was no recognized treatment for this disease which nevertheless affects between 600,000 and 1 million people in France and often represents psychological suffering for patients who feel disfigured,” continues Ms. Carré.
Developed by the American biotech Incyte, which already has several cancer therapies to its credit, but for which it is the first product marketed in dermatology, Opzelura aims to repigment affected areas in patients aged over 12 years. suffering from non-segmental vitiligo (i.e. which affects the body bilaterally), the most common form of this disease, provided that the vitiligo does not cover more than 10% of their total body surface area and also reaches the face.
The new direct access device
The results of phase 3 clinical trials, carried out in the United States and Europe, showed that applying the cream twice a day to the affected areas allowed 31% of the patients in the study to obtain an improvement of more than 75% in facial damage after six months, and 30% to see an improvement of more than 90% after one year.
On the basis of this promising data, the European Commission gave the green light in April 2023 to the marketing of this drug in Europe. But after having passed the caudine forks of the High Authority of Health, responsible in France for evaluating medicines with a view to their reimbursement, it still remained to conclude the long formalities of price negotiations with the Economic Committee of Health Products for be available to patients.
This last step, which can sometimes take more than a year, is still not completed today, but Opzelura has benefited from a brand new system created by the government: direct access. Inspired by the German model, this exceptional procedure, announced by Emmanuel Macron in 2021 during a strategic committee of health industries, a key moment of exchange between pharmaceutical manufacturers and public authorities, allows, under certain conditions, to make a medicine available to patients before discussions on setting its price have been completed. Objective: accelerate patients’ access to innovative treatments.
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