FDA reviewing Valeant's brodalumab

Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA accepted a BLA for brodalumab ( KHK4827) to treat moderate to severe plaque psoriasis. The PDUFA date for the human IgG2 mAb against IL-17 receptor (IL17R; IL17RA) is Nov. 16.

Valeant paid AstraZeneca plc (LSE:AZN; NYSE:AZN) $100 million up front in September 2015 for rights to brodalumab. Valeant has development and commercialization rights in all territories expect Japan and some other Asian markets, where Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) has rights (see BioCentury Extra, Sept.1, 2015). ...