Herriot Tabuteau, Axsome CEO (Photo by Owen Hoffmann/Patrick McMullan via Getty Images)

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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.