(AOF) – The European Commission has granted marketing authorization to Enjaymo (sutimlimab) for the treatment of haemolytic anemia in adults with cold agglutinin disease (CAD), an autoimmune haemolytic anemia chronic, rare and severe, which causes the immune system to mistakenly attack healthy red blood cells, causing them to break down or hemolyze. Enjaymo is currently the only drug approved for the treatment of FAD.
It is the first humanized monoclonal antibody in its pharmacotherapeutic class designed to specifically target and inhibit the serine protease specific to the classical complement pathway, the C1s complex. Enjaymo 50mg/ml will be presented as a solution for infusion.
Dr Dietmar Berger, Chief Medical Officer, Global Head, Development at Sanofi commented: “Until today in Europe, patients were forced to avoid exposure to cold, receive blood transfusions and take medication not indicated for the treatment of FAD to relieve their disease.The approval of the European Commission gives these patients for the first time access to a medicine that can significantly transform the management of this disease and their daily existence. ”