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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

DateArticle
Feb  5, 2022Approval FDA Approves Enjaymo (sutimlimab-jome) for Use in Patients with Cold Agglutinin Disease
Apr  7, 2021Positive Results from the Sutimlimab Pivotal Trial for People with Cold Agglutinin Disease Published in New England Journal of Medicine
Nov 13, 2020FDA Issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease
May 14, 2020FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease
Nov 21, 2019Pivotal Data from Phase 3 Study of Sutimlimab in Cold Agglutinin Disease to be Presented at ASH 2019 Late-Breaking Session

Further information

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