BioCentury
ARTICLE | Company News

More data could be key for Alkermes after FDA panel vote

November 2, 2018 11:32 PM UTC

After an FDA panel did not recommend approval of ALKS 5461 as an adjunct treatment for major depressive disorder (MDD), Alkermes plc (NASDAQ:ALKS) remained tight-lipped on next steps.

Members of a joint advisory panel voted 21-2 on Thursday that Alkermes' data did not support a favorable benefit risk balance to support approval (see “FDA Panel Snubs Alkermes’ Antidepressant”)...