Sanofi’s Enjaymo (sutimlimab) Receives EC’s Approval for Hemolytic Anemia in Adult Patients with Cold Agglutinin Disease
Shots:
• The approval was based on the part A P-III trials (CADENZA) & (CARDINAL) evaluating Enjaymo (6.5/7.5g, IV on Day 0, Day 7, and then EOW for ~26wk.) vs PBO in 42 & 24 patients with CAD. The product will be available as a 50mg/mL solution for infusion
• Both the trial met its 1EPs & 2EPs i.e., In the (CADENZA) study, the therapy showed inhibition of hemolysis, an increase in Hb levels & improvement in FACIT-Fatigue scores along with an acceptable safety profile & well- tolerated, patients experienced 1 TEAE (96% vs 100%) without a recent history of blood transfusion
• In the (CARDINAL) study, the efficacy was evaluated based on the 1EPs & different 2EPs incl. improvements in Hb, normalization of bilirubin & FACIT-fatigue score who have had a recent blood transfusion
Ref: Globenewswire | Image: Sanofi
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