Europe Approves Sanofi's Enjaymo For Rare Form Of Anemia

The European Commission has approved Sanofi SA SNY Enjaymo (sutimlimab) for hemolytic anemia in adult patients with cold agglutinin disease (CAD).
CAD is a rare chronic autoimmune hemolytic anemia, where the body's immune system mistakenly attacks healthy red blood cells, rupturing them (hemolysis).
Related: Europe Approves Sanofi, GSK's Beta Variant Adapted COVID Shot As Booster.
Enjaymo is currently the only approved treatment for CAD. It is a first-in-class humanized monoclonal antibody designed to selectively target and inhibit the classical complement pathway-specific serine protease, C1s.
The approval is based on data from two Phase 3 trials - CADENZA and CARDINAL.
In the CADENZA Part A study, Enjaymo met its primary composite endpoint and all secondary endpoints. It demonstrated hemolysis inhibition, hemoglobin levels increase, and clinically meaningful improvement in Fatigue scores.
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