Just two weeks after a rare rebuke from the Food and Drug Administration derailed Alkermes’s treatment for serious depression, the company has convinced the agency to change its mind and give the drug a chance.
On April 2, Alkermes said the FDA refused to even consider its approval application for a drug called ALKS-5461, citing “insufficient evidence of overall effectiveness” and sending the company’s share price down about 20 percent. On Monday, Alkermes CEO Richard Pops said the agency had reversed course, correcting a “misunderstanding” and putting ALKS-5461 on track for a yes or no decision by Jan. 31.
“I think it just took a while to get that lens focused the right way for FDA to accept the file,” Pops said on a conference call with analysts.
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