FDA approves first treatment for Ebola virus

FDA on Wednesday approved a combination of three monoclonal antibodies—atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb—Regeneron Pharmaceuticals)—as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adults and children. FDA Commissioner Stephen M.

FDA on Wednesday approved a combination of three monoclonal antibodies—atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb—Regeneron Pharmaceuticals)—as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adults and children. FDA Commissioner Stephen M. Hahn, MD, said: "Today's action demonstrates the FDA's ongoing commitment to responding to public health threats—both domestically and abroad—on the basis of science and data." The treatment was evaluated in 382 adults and children with confirmed Ebola virus infection in the PALM trial—which was led by the U.S. NIH and the DRC's Institut National de Recherche Biomédicale—and as part of an expanded access program conducted in the Democratic Republic of the Congo during an outbreak in 2018-19. The most commonly reported symptoms for people who took the drug combination were fever, chills, tachycardia, tachypnea, and vomiting—although these are also common symptoms of Ebola virus infection. FDA noted that patients who take "Inmazeb should avoid the concurrent administration of a live vaccine due to the treatment's potential to inhibit replication of a live vaccine virus indicated for prevention of Ebola virus infection and possibly reduce the vaccine's efficacy." Treatment should be discontinued in the event of a hypersensitivity reaction, including infusion-related events. FDA approved Ervebo, the first vaccine for the prevention of Ebola virus disease, in December 2019.