Sanofi Presents Results of Sutimlimab in P-III CADENZA Trial to Treat Hemolysis Patients with Cold Agglutinin Disease at EHA 2021

Shots:

• Part A of the P-III CADENZA trial involves assessing the efficacy & safety of sutimlimab (6.5g/ 7.5g) vs PBO in a ratio (1:1) in 42 patients with CAD without blood transfusion. The study met its 1EPs i.e. improvement in Hgb ≥1.5 g/dL from baseline @23, 25, & 26wks., avoidance of transfusions & other CAD-related therapies @5wks. through 26wks.
• The 2EPs includes improvement in Hgb levels from baseline @26 wks., improvement in fatigue, bilirubin, LDH levels, & QoL as measured by FACIT-Fatigue score
• Sutimlimab inhibits C1-activated hemolysis within 1wk. treatment. Sanofi plans to resubmit BLA of the therapy to US FDA in H2’21

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