“This is big news for patients! We waited for this moment with great impatience. », says Martine Carré, President of the French Vitiligo Association. Opzelura, the first-ever drug designed to treat people with vitiligo, this chronic autoimmune disease that causes progressive depigmentation of the epidermis and hair system and is characterized by white patches on the face and body, is now available in France by decree , which was published in Official newspaperWednesday, January 31st.
“ To date, there has been no recognized treatment for this disease, which nevertheless affects between 600,000 and 1 million people in France and often causes psychological suffering for patients who feel disfigured. », continues MMe Square.
Developed by the American biotech company Incyte, which already has several anti-cancer therapies but for which it is the first product marketed in dermatology, Opzelura aims to repigment affected areas in patients over 12 years old suffering from non-segmental vitiligo (that is, affecting the body on both sides), the most common form of this disease, provided that vitiligo does not cover more than 10% of the total body surface and also reaches the face.
The new direct access device
The results of phase 3 clinical trials conducted in the United States and Europe showed that applying the cream twice daily to the affected areas provided an improvement of more than 75% in facial damage in 31% of patients in the study after six months and 30%, an improvement of more than 90% after one year.
Based on these promising data, the European Commission gave the green light for the marketing of this drug in Europe in April 2023. But after passing the Caudine forks of the High Authority for Health, which in France is responsible for evaluating medicines with a view to their reimbursement, the long formalities of price negotiations with the Economic Committee for health products available to patients still had to be completed .
This final step, which can sometimes take more than a year, is not yet completed today, but Opzelura has benefited from a completely 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 the Health Industries, an important moment of exchange between pharmaceutical manufacturers and authorities, allows, under certain conditions, the provision of a medicine to patients in advance of the discussions to determine the Prices are completed. Goal: Accelerate patient access to innovative treatments.
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