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Regeneron’s drug becomes first FDA-approved Ebola virus treatment

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The US Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals’ triple anti-body cocktail as the first Ebola virus 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 Ebola virus infection in a clinical trial, the health regulator said.

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

The treatments are part of a class of drugs known as monoclonal anti-bodies, which are manufactured copies of anti-bodies 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.

 

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