Inmazeb Gets First FDA Approval for Ebola Treatment
Atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb), a monoclonal antibody cocktail ffor the treatment of adult and pediatric patients with Ebola virus infection, becomes the first drug approved to treat Ebola virus.
The FDA has approved atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) for the treatment of adult and pediatric patients with Zaire ebolavirus (Ebola virus) infection. With the indication, the monoclonal antibody cocktail from Regeneron Pharmaceuticals becomes the first drug approved to treat Ebola virus. The 3-drug combination therapy is designed to target the glycoprotein located on the virus' surface, and inhibit its attachment to the cell receptor, stopping the virus from entering cells.
Its efficacy and safety was observed the PALM trial, a 382-adult and -pediatric patient assessment led by the US National Institutes of Health (NIH) and DRC's Institut National de Recherche Biomédicale as part of the expanded access program conducted in the Democratic Republic of the Congo (DRC) during an outbreak in 2018-2019. The multi-center, open-label, randomized controlled study compared 154 patients administered 50 mg of each monoclonal antibody in Inmazeb intravenously in a single infusion, versus 168 patients on investigational control therapy. Primary efficacy endpoint was 28-day mortality.
One-third (33.8%) of patients treated with Inmazeb died after 28 days, versus 51% of control patients. Investigators provided the therapy to another 228 patients in the expanded access program. The most common symptoms reported among treated patients included fever, chills, tachycardia, tachypnea, and vomiting—symptoms also closely associated with Ebola virus infection.