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The Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals' Inmazeb as the first treatment for the Ebola virus.
Why it matters: The approval comes after the World Health Organization announced in June that the world’s second-largest Ebola outbreak had been eradicated in the Democratic Republic of the Congo. There were over 3,400 cases and over 2,200 deaths, according to data from WHO.
Details: Inmazeb, a mixture of three antibodies, was tested on 382 adults and children with confirmed Zaire ebolavirus infection in a clinical trial conducted in the Democratic Republic of the Congo during an Ebola outbreak between 2018 and 2019, the FDA said.
What they're saying: “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.
Department of Health and Human Services Secretary Alex Azar called the approval “a momentous global health achievement that would have never occurred without American leadership.”
- "The United States was proud to provide direct support for this treatment, through an expanded access protocol and a clinical trial conducted in a highly dangerous and insecure region of the DRC," Azar said.
- "The Trump Administration made ending the 2018 Ebola outbreak one of its top global health priorities for the last two years, and these efforts have now left the U.S. and our African partners better prepared for the fight against the new outbreak in western DRC and for future health threats.”
Flashback: Ervebo became the first FDA-approved vaccine for the prevention of the Ebola virus in December 2019, supported by a study in Guinea conducted during a 2014-2016 outbreak.