Bioverativ`s Biologic Enjaymo (sutimlimab) Receives Approval in the U.S.
New drug approvals were fewer in number in 2022. Is this a trend that will continue into 2023 or is the drop off just a cyclical anomaly?
The European Commission (EC) has granted marketing authorisation for Enjaymo® (sutimlimab), as the only approved treatment of haemolytic anaemia in adults with cold agglutinin disease (CAD).
EC approves Enjaymo for treatment of hemolytic anemia
Genzyme`s Enjaymo (sutimlimab) Receives Approval in the Europe
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 haemolytic anaemia in adult patients with cold agglutinin disease (CAD). CAD is a rare, serious, and chronic autoimmune haemolytic anaemia.
Paris, September 16, 2022. 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). CAD is a rare, serious, and chronic autoimmune hemolytic anemia.
Bioverativ Therapeutics' Biologic Enjaymo (Sutimlimab) Receives Approval in U.S.
A second phase 3 clinical trial of Sanofi’s sutimlimab in people with cold agglutinin disease has met its primary endpoint. The success of the second clinical trial positions Sanofi to seek approval for the C1s inhibitor in the EU.