Alkermes PLC will likely need to conduct another efficacy trial if it wants to continue to seek approval for its major depressive disorder (MDD) candidate ALKS 5461, as a US FDA advisory panel overwhelmingly voted against the drug's risk/benefit profile by a 21-2 margin at a Nov. 1 meeting.
Members of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee overall felt the sponsor failed...