Will Alkermes Data Package Support ALKS 5461 Approval?
Alkermes revealed successful completion of its third Phase III trial for the depression drug ALKS 5461 as well as a risky plan to seek FDA approval based on two negative and one positive late-stage study.
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CEO Richard Pops called FDA's letter for ALKS 5461 "surprising and troubling." Alkermes had been ramping up to launch the depression drug later this year, though some investors had remained skeptical.
The latest drug development news and highlights from our US FDA Performance Tracker.
CEO Jeff Jonas said the rapid and durable response to just two weeks of treatment with SAGE-217 coupled with the oral drug's safety in a short-term Phase II study support first-line use of the novel therapy, but plans for a Phase III depression program are not yet known.