FDA Approves Regeneron’s Inmazeb To Treat Ebola

The U.S. Food and Drug Administration has approved Inmazeb, an antibody cocktail made by Regeneron Pharmaceuticals Inc. (REGN), for the treatment of infection caused by Zaire ebolavirus (Ebola virus) in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

Inmazeb or REGN-EB3 is a mixture of atoltivimab, maftivimab, and odesivimab-ebgn monoclonal antibodies.

In a large clinical trial, Inmazeb showed superiority compared to other investigational agents (ZMapp and remdesivir) with respect to mortality. The treatment was most effective when given early in the course of disease, Regeneron said in a statement on Wednesday.

Inmazeb was evaluated in 382 adult and pediatric patients with confirmed Zaire ebolavirus infection in PALM clinical trial, and as part of an expanded access program conducted in the Democratic Republic of the Congo (DRC) during an Ebola virus outbreak in 2018-2019.

In the PALM trial, the safety and efficacy of Inmazeb was evaluated in a multi-center, open-label, randomized 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.

Of the 154 patients who received Inmazeb, 33.8% died after 28 days, compared to 51% of the 153 patients who received a control drug.

The FDA advised that patients who receive Inmazeb should avoid getting a live Ebola vaccine at the same time, because the drug may reduce the vaccine’s efficacy.

The FDA approved Ervebo, the first vaccine for the prevention of Ebola virus disease, in December 2019.

In March 2014, the World Health Organization (WHO) reported a major Ebola outbreak in Guinea, a western African nation. The disease then rapidly spread to the neighboring countries of Liberia and Sierra Leone.

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