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Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections

 
• By Joseph Haas

Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.

Hand drawn failure in business. Unfortunate attempt to hit the target
Alkermes gets a complete response letter but it's only CMC issues that are off-target

Alkermes plc announced receipt of a complete response letter from the US Food and Drug Administration for its new drug application for ALKS 3831 for schizophrenia and bipolar disorder on 17 November due to a manufacturing issue. The FDA denied approval by the 15 November action date, not because of safety and efficacy questions but because the FDA could not conduct a physical site inspection due to the COVID-19 pandemic.

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