An FDA advisory panel Thursday panned a new experimental drug for depression from Alkermes, meaning the agency is likely to reject the treatment by early next year.
By a 21 to 2 vote, the 23 experts decided that the data accrued by Alkermes (NASDAQ: ALKS) don’t support approval of the drug, currently known as ALKS-5461. They also voted 20 to 3 that Alkermes hasn’t provided substantial evidence that the drug is effective.
Though the results of these meetings aren’t binding, the FDA looks to its advisory panels for guidance and its approval decisions are often in line with the panel… Read more »
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