FDA Approves Ridgeback Biotherapeutics’ Ebanga for Treating Ebola Virus
The FDA has approved Ridgeback Biotherapeutics’ monoclonal antibody Ebanga (ansuvimab-zykl) for treating adults and children infected with the Ebola virus.
The approval was supported by results from a phase 2/3 study in 342 infected participants randomized to receive either Ebanga or placebo, with more than 35 percent of those treated with Ebanga dying after 28 days vs. more than 49 percent in the placebo group.
The study took place during the 2018-2019 Ebola outbreak in the Democratic Republic of the Congo (DRC) and was overseen by the National Institutes of Health and the DRC’s Institut National de Recherche Biomédicale.
The treatment, which inhibits the virus’ ability to bond to healthy cell receptors, previously received Orphan Drug and Breakthrough Therapy designations from the FDA.