EMA Recommends Approval of Enjaymo

Sanofi announced on Sept. 16, 2022 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Enjaymo (sutimlimab) for the treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD).

CAD is a serious, rare, and chronic autoimmune hemolytic anemia, where the part of the body’s immune system mistakenly destroys healthy red blood cells (hemolysis). According to a company press release, CAD impacts the lives of an estimated 12,000 people in the United States, Europe, and Japan, and is associated with profound fatigue and increased risk of thromboembolic events and mortality.

Enjaymo was approved by FDA in February 2022 and is the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. The European Commission will review the CHMP recommendation, with an anticipated decision by the end of 2022.