On Tuesday, July 19, 2016, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) supported, by a vote of 14 for “Yes, but only if certain risk management options for Suicide Ideation and Behavior (SIB) beyond labeling are implemented”, the overall benefit/risk profile of brodalumab as acceptable to support approval for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Four of the Committee members voted for “Yes, with labeling alone to manage the risks.” No members voted for “No.”
See the SAC Tracker report