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

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Sanofi