FDA experts gun down Alkermes’ pitch for ALKS-5461, slamming the company on multiple fronts
A large group of outside experts at the FDA has slapped down Alkermes’ campaign to gain an approval for their depression drug ALKS-5461, objecting to a messy set of data and the way the biotech managed the study and reported the data.
The key question: Did Alkermes present substantial evidence of the drug’s efficacy? Twenty panel members voted no, with only 3 yes votes, which makes it extremely unlikely that the FDA’s formal decision would be any different.
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