Sanofi’s Enjaymo OK’d for Cold Agglutinin Disease

FDA has approved a Sanofi BLA for Enjaymo (sutimlimab-jome) for decreasing the need for red blood cell transfusions due to hemolysis in adults with cold agglutinin disease (CAD). The rare autoimmune hemolytic anemia is caused by antibodies (cold agglutinins) binding to the surface of red blood cells, which causes the body’s immune system to mistakenly attack healthy red blood cells. The company says the therapy works by inhibiting the destruction of red blood cells.

Approval was based in data from Sanofi’s 24-patient CARDINAL study that met its primary efficacy endpoint of the predetermined proportion of patients who achieved normalization of hemoglobin level or demonstrated an increase from baseline in their hemoglobin, according to the company. The most common adverse reactions occurring in 10% or more of patients were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.