THURSDAY, Oct. 15, 2020 -- The first drug for Zaire ebolavirus (Ebola virus) infection has been approved for adults and children, the U.S. Food and Drug Administration announced Wednesday.
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) is a mixture of three monoclonal antibodies that simultaneously block entry of the virus. The approval also applies to newborns of mothers who have tested positive for Ebola virus.
The drug's approval was based on data from the PALM trial, a multicenter, open-label, randomized controlled trial conducted in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018 to 2019. The study involved 382 adults and children with confirmed Ebola virus infection; 154 patients received a single infusion of intravenous Inmazeb (50 mg of each monoclonal antibody) and 168 received an investigational control. At 28 days, 33.8 and 51 percent of patients who received Inmazeb and the investigational control, respectively, had died.
The most common symptoms that patients reported whole receiving Inmazeb were fever, chills, tachycardia, tachypnea, and vomiting. The FDA notes these are also common symptoms of Ebola virus. Patients may also experience hypersensitivity and infusion-related events. The agency notes that patients receiving Inmazeb should avoid concurrently receiving a live vaccine because Inmazeb may reduce the vaccine's efficacy.
Approval was granted to Regeneron Pharmaceuticals.