Posted by Michael Wonder on 14 Oct 2020
FDA approves first treatment for Ebola virus
14 October 2020 - Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and paediatric patients.
In the PALM trial, the safety and efficacy of Inmazeb was evaluated in a multi-center, open-label, randomised controlled trial, in which 154 patients received Inmazeb (50 mg of each monoclonal antibody) intravenously as a single infusion, and 168 patients received an investigational control.
Inmazeb received an orphan drug designation for the treatment of Ebola virus infection. Additionally, the agency granted Inmazeb a breakthrough therapy designation for the treatment of Zaire ebolavirus infection.
