Axsome's migraine drug issued CRL a week after the biotech outlined CMC concerns
A week after New York-based Axsome Therapeutics said it expected a CRL for its migraine drug, the biotech reported Monday that the FDA has followed through.
The principal reasons given in the CRL are related to chemistry, manufacturing and controls (CMC) considerations, Axsome reiterated Monday. The letter identified the need for some additional CMC data about the drug product itself as well as the manufacturing process, according to Axsome. The biotech believes the issues raised can be addressed and intends to provide potential timing for a resubmission following consultation with the FDA. The letter did not raise any efficacy issues, Axsome said.
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