EU Committee Recommends Approval for Sanofi's Cold Agglutinin Disease Treatment
The European Medicines Agency's CHMP has recommended approval for Sanofi's Enjaymo (sutimlimab) as a treatment for hemolytic anemia in adult patients with cold agglutinin disease. This marks a significant step towards a new therapeutic option for this rare condition.
PARIS – September 16, 2022 – Sanofi announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Enjaymo (sutimlimab) within the European Union. The drug is intended for the treatment of hemolytic anemia in adult patients diagnosed with cold agglutinin disease (CAD), a rare autoimmune disorder.
The CHMP's recommendation is based on findings from two Phase 3 clinical trials: CADENZA and CARDINAL. The CADENZA trial evaluated sutimlimab in patients with CAD who had not received a blood transfusion within the prior six months. The CARDINAL trial focused on patients with CAD who had recently undergone a blood transfusion.
Enjaymo, a humanized monoclonal antibody, works by inhibiting C1s, a protein in the classical complement pathway. This mechanism targets the activation of the complement cascade, which is implicated in the destruction of red blood cells in CAD. The therapy aims to reduce the breakdown of healthy red blood cells without affecting other immune system pathways.
Cold agglutinin disease affects an estimated 12,000 individuals across the U.S., Europe, and Japan, leading to chronic anemia, fatigue, and an increased risk of thromboembolic events. The European Commission is expected to make a final decision on the drug's approval by the end of 2022. Enjaymo received FDA approval in the U.S. in February 2022 for a similar indication.