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FDA Issues CRL For Sanofi's Sutimlimab Due To Deficiencies In Third-party Manufacturing Facility

Sanofi (SNYNF,SNY) said that the U.S. Food and Drug Administration issued a complete response letter or CRL regarding the biologics license application or BLA for sutimlimab. The complete response letter refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing.

Sutimlimab is an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.

Sanofi said that there were no clinical or safety deficiencies noted in the CRL with respect to the application. Satisfactory resolution of the observations by the third-party manufacturer is required before the BLA can be approved.

Sanofi said it remains in contact with the FDA and the third-party manufacturer to reach a resolution in a timely manner.

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