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FDA approves Dupixent for atopic dermatitis in adolescents

March 11, 2019 10:32 PM UTC

FDA on Monday approved the first biologic for adolescents with moderate-to-severe atopic dermatitis, Dupixent dupilumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY).

The partners already market the human mAb targeting the α subunit of IL-4RA and the IL-13 receptor in the U.S. to treat adults with moderate-to-severe atopic dermatitis not adequately controlled with topical therapies. The drug is also approved for maintenance treatment of moderate-to-severe eosinophilic or corticosteroid-dependent asthma in patients ages 12 and older...