The US FDA gave its blessing to Valeant Pharmaceuticals International Inc.'s psoriasis treatment Siliq (brodalumab), but without a four-letter suffix the agency said it would require for novel biologics and biosimilars.
A monoclonal antibody, brodalumab was approved Feb. 15 for the treatment of adults with moderate to severe plaque psoriasis. The approval comes with strict regulatory safeguards, including a Risk Evaluation and Mitigation Strategy (REMS) and a boxed warning for suicidal ideation and behavior