Alkermes PLC is betting that the novel design of its Phase III clinical trials, including the recently positive FORWARD-5 trial and two previously failed studied, and its overall data package will be enough to convince the FDA to approve its depression drug ALKS 5461 – a risky approach in a tough indication.
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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