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# Complete Response Letter on Sanofi BLA
- URL: https://www.fdaweb.com/complete-response-letter-on-sanofi-bla/
- Published: 2020-11-16T12:00:00.000Z
- Updated: 2026-09-14T16:36:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148094

FDA has issued Sanofi a complete response letter (CRL) on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with cold agglutinin disease. The letter refers to deficiencies identified by the agency during a pre-license inspection of an unnamed third-party facility responsible for manufacturing, according to Sanofi, adding that there were no clinical or safety deficiencies noted in the CRL. “Satisfactory resolution of the observations by the third-party manufacturer is required before the BLA can be approved and Sanofi remains in close contact with the FDA and the third-party manufacturer to reach a resolution in a timely manner,” it says.