Brodalumab regulatory update

FDA accepted for review a BLA from Valeant for brodalumab to treat moderate to severe plaque psoriasis. The PDUFA date is Nov. 16. Valeant has exclusive rights to develop and commercialize the human IgG2 mAb against IL-17 receptor (IL17R; IL17RA) from AstraZeneca outside of Japan and undisclosed Asian countries (see BioCentury, Sept. 7, 2015). Last quarter, EMA accepted for review an MAA for brodalumab to treat psoriasis. ...