FDA grants first-ever Ebola drug approval to Regeneron

Regeneron’s Inmazeb gained FDA approval Oct. 14, becoming the first Ebola treatment to receive approval by the agency.

The drug is a mixture of three monoclonal antibodies that target the Zaire ebolavirus strain, one of the four strains that can be fatal to humans. Patients are given the treatment once, and it is administered intravenously. 

Inmazeb was tested in the Democratic Republic of Congo during an Ebola outbreak that killed nearly 2,300 people before it ended in June. The drug significantly improved study participants’ chances of survival when compared to a second experimental drug. 

“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, MD, said in a news release. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”

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