The National Medical Products Administration (NMPA) in China has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The NMPA identified Dupixent as an overseas medicine considered urgently needed in clinical practice, leading to an expedited review and approval process.
“Sanofi has deep roots in China, and it continues to be a significant area of growth for us. New regulations have paved the way for first-in-class treatments like Dupixent to be delivered to patients sooner and, in partnership with the government’s Healthy China 2030 initiative, we plan to seek approval by 2025 for more than 25 innovative medicines for chronic and rare diseases and vaccines,” said Paul Hudson, Chief Executive Officer, Sanofi. “The approval of Dupixent in China offers a new treatment option with an established safety and efficacy profile. This is a meaningful advance for patients and their physicians who have struggled to treat the debilitating symptoms of moderate-to-severe atopic dermatitis which can seriously impact quality of life.”
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
“As the first biologic medicine approved for moderate-to-severe atopic dermatitis, Dupixent has transformed the treatment landscape for patients around the world by targeting the type 2 inflammation that underlies the disease, rather than broadly suppressing the immune system,” said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron. “More than 150,000 people have already been treated with Dupixent globally and today’s approval brings this novel treatment to those in China who are in urgent need of new options.”