FDA panel snubs Alkermes’ antidepressant

An FDA panel voted 21-2 that Alkermes plc (NASDAQ:ALKS) did not demonstrate a favorable benefit risk profile for ALKS 5461 to support approval for adjunct treatment of major depressive disorder.

Panelists also voted 20-3 that Alkermes had not shown substantial evidence of efficacy for ALKS 5461; they voted 13-10 that Alkermes had adequately characterized the safety profile. The joint panel comprised members of FDA’s Psychopharmacological Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee...