MedWatch

Axsome Therapeutics steels itself for FDA rejection of migraine drug

According to the US health authority, Axsome Therapeutics has been unable to solve a number of problems with its manufacturing conditions for migraine candidate AXS-07, and as a consequence, the US-based firm is preparing for the drug’s final rejection.

A new migraine candidate is seemingly not making it all the way to market | Photo: Andrew Kelly/Reuters/Ritzau Scanpix

An increase in Covid-19 cases delayed the US Food and Drug Administration’s (FDA) planned manufacturing site inspections of Axsome Therapeutics, which left the company waiting for answers for one of its pending candidates, as reported by industry media Fierce Biotech.

As it turns out, not all things come to those who wait, as the FDA has reportedly filed a report with the US Securities and Exchange Commission (SEC) that identifies chemistry, manufacturing and control issues in the application regarding AXS-07, a migraine treatment, concluding that problems were left “unresolved.”

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