FDA Approves First Ebola Virus Treatment

By Deena Beasley

October 15, 2020

(Reuters) - The U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals' triple antibody cocktail as the first Ebola treatment, lending validation to similar drugs being developed for COVID-19.

Regeneron's Inmazeb, an intravenous drug, has been approved for adults and children, after it was tested in 382 candidates with confirmed Zaire ebolavirus infection in a clinical trial, the health regulator said.

The drugmaker has said it is talking with the FDA about an emergency use authorization for its experimental dual antibody cocktail for COVID-19, which was given to U.S. President Donald Trump as part of his treatment regime.

The treatments are part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies that are one of the main weapons generated by the immune system to fight infections.

"Today's action demonstrates the FDA's ongoing commitment to responding to public health threats — both domestically and abroad — on the basis of science and data," FDA Commissioner Stephen Hahn said in a media statement.

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

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....