Sanofi’s Sutimlimab Receives the US FDA’s Priority Review to Treat Hemolysis Patients with Cold Agglutinin Disease

Shots: Shots:

• The BLA submission is based on part A of P-III CARDINAL study in patients with primary CAD. The study met its 1EPs i.e. patients demonstrated an increase from baseline in Hgb level ≥2 g/dL or normalization of Hgb level ≥12 g/dL at the treatment assessment time point (mean value from @23, 25, and 26wks.) with no blood transfusion from @5wks. through 26wks.
• The study also met its 2EPs i.e. improvement in disease process including improvements in hemoglobin and Functional Assessment of Chronic Illness Therapy-Fatigue Score with a normalization of bilirubin
• Sutimlimab selectively targets and inhibit C1s in the classical complement pathway, currently being evaluated in the on-going P-III CADENZA study for CAD patients, not having a blood transfusion and investigating sutimlimab for patients with immune thrombocytopenic purpura. If approved, the therapy would be the first and only approved treatment for CAD with its PDUFA date as Nov 13, 2020

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