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Sutimlimab FDA Approval Status

Last updated by Judith Stewart, BPharm on May 19, 2020.

FDA Approved: No
Generic name: sutimlimab
Company: Sanofi
Treatment for: Cold Agglutinin Disease (CAD)

Sutimlimab is a first-in-class selective inhibitor of complement C1s in development for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD).

Development Timeline for sutimlimab

Apr  7, 2021Positive Results from the Sutimlimab Pivotal Trial for People with Cold Agglutinin Disease Published in New England Journal of Medicine
Nov 13, 2020FDA Issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease
May 14, 2020FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease
Nov 21, 2019Pivotal Data from Phase 3 Study of Sutimlimab in Cold Agglutinin Disease to be Presented at ASH 2019 Late-Breaking Session

Further information

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