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Inmazeb FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 19, 2021.

FDA Approved: Yes (First approved October 14, 2020)
Brand name: Inmazeb
Generic name: atoltivimab, maftivimab, and odesivimab-ebgn
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Ebola Zaire Disease Prophylaxis

Inmazeb is (atoltivimab, maftivimab, and odesivimab) is a monoclonal antibody combination indicated for the treatment of Zaire ebolavirus infection in adults and children, including newborns of mothers who have tested positive for the virus.

  • The monoclonal antibodies in Inmazeb target the Zaire ebolavirus glycoprotein on the surface of the virus. The antibodies bind to the glycoprotein, blocking its attachment to cell receptors and preventing entry of the virus into the cells.
  • Inmazeb is administered as a single intravenous infusion.
  • Inmazeb may cause hypersensitivity reactions, including infusion-related events which can be severe or life-threatening. Common adverse events (incidence ≥20%) include pyrexia, chills, tachycardia, tachypnea, and vomiting.

Development timeline for Inmazeb

Oct 14, 2020Approval FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)
Jul 29, 2020BARDA Procures Regeneron's REGN-EB3 Investigational Ebola Treatment for National Preparedness
Apr 16, 2020FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
Nov 27, 2019New England Journal of Medicine Publishes Results of Ebola Clinical Trial Confirming Superiority of Regeneron's REGN-EB3 to ZMapp in Preventing Ebola Deaths
Aug 12, 2019PALM Ebola Clinical Trial Stopped Early as Regeneron's REGN-EB3 Therapy Shows Superiority to ZMapp in Preventing Ebola Deaths

Further information

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