Dupilumab under FDA review for atopic dermatitis

Sanofi (Euronext:SAN; NYSE:SNY) and partner Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) said FDA accepted and granted Priority Review to a BLA for dupilumab ( REGN668) to treat adults with inadequately controlled moderate to severe atopic dermatitis. The PDUFA date is March 29, 2017.

In April, the partners said dupilumab met the primary endpoint in the identical Phase III LIBERTY AD SOLO 1 and SOLO 2 trials to treat moderate to severe atopic dermatitis (see BioCentury Extra, April 1). ...