Enjaymo FDA Approval History
Last updated by Judith Stewart, BPharm on March 21, 2022.
FDA Approved: Yes (First approved February 4, 2022)
Brand name: Enjaymo
Generic name: sutimlimab-jome
Dosage form: Injection
Company: Sanofi
Treatment for: Cold Agglutinin Disease
Enjaymo (sutimlimab-jome) is a classical complement inhibitor indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
- Cold agglutinin disease is a rare autoimmune hemolytic anemia. Antibodies called cold agglutinins bind to the surface of red blood cells which body’s immune system mistakenly attacks to cause hemolysis.
- Enjaymo is a humanized monoclonal antibody that works by inhibiting the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy red blood cells.
- Enjaymo is administered via intravenous infusion weekly for the first two weeks, then every two weeks thereafter.
- Warnings and precautions associated with Enjaymo include serious infections, infusion-related reactions, risk of autoimmune disease, and recurrent hemolysis after discontinuation of Enjaymo.
- Common adverse reactions include respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.
Development timeline for Enjaymo
Further information
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