FDA grants priority review of sutimlimab, potential first approved treatment of haemolysis in adult patients with cold agglutinin disease

Sanofi

14 May 2020 - Sutimlimab targets C1-activated haemolysis in cold agglutinin disease.

The U.S. FDA has granted priority review of Sanofi’s biologics license application for sutimlimab for the treatment of haemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of haemolysis in CAD by selectively inhibiting complement C1s.

If approved, sutimlimab would be the first and only approved treatment for these patients. The target action date for the FDA decision is 13 November 2020.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review