Regeneron's drug becomes first FDA-approved Ebola virus treatment
The drugmaker has said it is now talking with the FDA about an emergency use authorisation for its experimental dual antibody cocktail for Covid-19.
Arlette Kavugho, 40, a mother of six and an Ebola survivor who works as a caregiver, carries Kambale Eloge, 16 months old, whose mother died of Ebola, during her visit to the United Nations Children's Fund (UNICEF) creche for children whose families are suspected or confirmed Ebola cases, in Katwa, near Butembo, in the Democratic Republic of Congo, October 2, 2019.
The US Food and Drug Administration has approved Regeneron Pharmaceuticals' triple antibody cocktail as the first Ebola virus treatment, lending validation to similar drugs being developed for Covid-19.
Regeneron's Inmazeb, an intravenous drug, was approved on Wednesday for adults and children, after it was tested in 382 candidates with 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 authorisation for its experimental dual antibody 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 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 confirmed 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.
READ MORE: Second deadliest Ebola outbreak on record ends in DRC
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