FDA Grants Sanofi’s Sutimlimab Priority Review

The FDA granted a priority review to Sanofi’s sutimlimab for treatment of patients with cold agglutinin disease (CAD), a condition that causes the immune system to destroy the body’s red blood cells.

Sutimlimab selectively inhibits immune system proteins that cause the destruction of red blood cells in CAD patients.

If approved, sutimlimab would be the first approved treatment for CAD patients. The FDA is expected to make a decision on the drug by Nov. 13.