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Refusal Reversal: Alkermes Review Back On Track, But Could Still Be Bumpy

 
• By Jessica Merrill

US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.

In a surprising turn of events, the US FDA reversed its refuse-to-file decision on Alkermes PLC's depression drug ALKS 5461, but the quick change of course could mean the agency's questions will need to be addressed in the standard review process instead.

Alkermes announced April 16 that FDA has accepted an NDA for ALKS 5461 as an adjunctive therapy for the treatment of major depressive disorder after initially issuing a refuse-to-file (RTF) letter

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