The FDA approved the first treatment for Ebola, a monoclonal antibody cocktail consisting of atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb), the agency announced on Wednesday.
Inmazeb, administered via infusion, was approved for adult and pediatric patients based on the results of the PALM trial, which examined multiple Ebola therapeutics.
Of the 154 patients in the trial who received Inmazeb (previously called REGN-EB3 after its manufacturer, Regeneron Pharmaceuticals), 33.8% died after 28 days compared to 51% of the 153 patients receiving control medication.
“Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” John Farley, MD, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The PALM trial was jointly run by the National Institutes of Health and the Democratic Republic of the Congo. Inmazeb was one of two therapies to show effectiveness, the other being another monoclonal antibody treatment, mAb114, developed by the National Institute of Allergy and Infectious Diseases.
The trial was stopped in August 2019 after both Inmazeb and mAb114 showed effectiveness compared to the monoclonal antibody ZMapp and investigational antiviral remdesivir, with all patients then advised to be treated with either of the two more effective therapies. The FDA said an additional 228 patients received Inmazeb under an expanded access program, and the drug had previously received an orphan drug designation from the agency.
The most common adverse events associated with Inmazeb were fever, chills, and tachycardia. Patients should also avoid concurrent administration of a live Ebola virus vaccine, which may limit the vaccine’s efficacy, the agency said. The FDA added that hypersensitivity and infusion-related events can also occur, and treatment should be discontinued in the event of a hypersensitivity reaction.
FDA Commissioner Stephen Hahn, MD, characterized the approval in a statement as part of “the FDA’s ongoing commitment to responding to public health threats — both domestically and abroad — on the basis of science and data.”