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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.