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

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

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  • 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

  | Ref: GlobeNewswire | Image: Pharmaceutical Technology

Click here to­ read the full press release 

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