3:32 PM
Mar 11, 2019
 |  BC Extra  |  Company News

FDA approves Dupixent for atopic dermatitis in adolescents

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.

An sBLA for Dupixent is under FDA Priority Review as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. The PDUFA date is June 26 (see "Phase III Nasal Polyps Data for Dupixent Presented at AAAAI").

Regeneron was up $9.41 to $412.05 on Monday. The partners announced the news just before market close.

Targets: IL-4R (IL-4RA; CD124) - Interleukin-4 receptor; IL-13 - Interleukin-13

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