(CercleFinance.com) – Sanofi announces that the United States FDA has approved Enjaymo (sutimlimab-jome) to reduce the need for red blood cell transfusions to treat hemolysis in adults with cold agglutinin disease ( MY F).
Affecting nearly 5,000 people in the United States, this rare autoimmune hemolytic anemia is caused by the presence of antibodies that trigger a process that causes the immune system to mistakenly attack healthy red blood cells.
This approval of Enjaymo, obtained after a priority review, was based on the positive results of a pivotal phase III study of 26 weeks, called CARDINAL. The product should be available in the United States in the coming weeks.