Sanofi : FDA Approves Enjaymo, First Treatment For Use In Patients With Cold Agglutinin Disease

(RTTNews) - Sanofi (SNYNF, SNY) said that the U.S. Food and Drug Administration has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease or CAD.

Enjaymo is the first and only approved treatment for people with cold agglutinin disease and works by inhibiting the destruction of red blood cells (hemolysis).

Cold agglutinin disease, a rare autoimmune hemolytic anemia, is caused by antibodies called cold agglutinins binding to the surface of red blood cells, which starts a process that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis).

As red blood cells have the vital job of carrying oxygen throughout the body, patients with cold agglutinin disease may experience severe anemia, which can result in fatigue, weakness, shortness of breath, light-headedness, chest pain, irregular heartbeat, and other potential complications. cold agglutinin disease is a chronic and rare blood disorder that impacts the lives of an estimated 5,000 people in the U.S.

The recommended dose of Enjaymo is based on body weight (6,500 mg for people 39-75 kg and 7,500 mg for people >75 kg). Enjaymo is administered intravenously weekly for the first two weeks with administration every two weeks thereafter.

Enjaymo is expected to be available in the U.S. in the coming weeks. The U.S. list price, or wholesale acquisition cost, of Enjaymo is $1,800 per vial. Actual costs to patients are generally anticipated to be lower as the list price does not reflect insurance coverage, co-pay support, or financial assistance from patient support programs.