Sanofi gets EMA Committee recommendation for approval of Enjaymo for hemolytic anemia in adult patients with cold agglutinin disease
Paris: Sanofi has recently announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Enjaymo (sutimlimab), recommending that the C1 protein (C1s) inhibitor be approved in the European Union (EU) for treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD).
Enjaymo is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy red blood cells. Enjaymo does not inhibit the lectin and alternative pathways.
CAD is a rare, serious, and chronic autoimmune hemolytic anemia, where part of the body's immune system mistakenly destroys healthy red blood cells (hemolysis).
The positive CHMP opinion is based on data from two Phase 3 clinical trials: CADENZA, a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months), and CARDINAL, a 26-week open-label, a single-arm pivotal study in patients with CAD who have had a recent blood transfusion.
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