Siliq regulatory update

FDA approved a BLA from Valeant for Siliq brodalumab to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have stopped responding to other systemic therapies. Next half, the company plans to launch the human IgG2 mAb against IL-17 receptor (IL17R; IL7RA). Siliq's label includes a boxed warning noting risks of suicidal ideation and behavior (SIB) and the drug has a REMS. Valeant has exclusive rights to develop and commercialize brodalumab from AstraZeneca outside of Japan and undisclosed Asian countries (see BioCentury, Sept. 7, 2015)...