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The FDA has approved the first treatment for Ebola


There is now an approved treatment for Ebola, one of the deadliest diseases in the world.

The U.S. Food and Drug Administration announced on Oct. 14 that Inmazeb, a laboratory-manufactured antibody cocktail developed by pharmaceutical company Regeneron, can be used to treat adult and pediatric Ebola patients. The announcement comes less than a year after the FDA green-lit the first Ebola vaccine (SN: 20/12/19).

“This is a great development,” says Erica Ollmann Saphire, an immunologist at the La Jolla Institute of Immunology in San Diego, California. The Ebola virus causes serious illnesses, including fever, vomiting, diarrhea, and bleeding. Outbreaks of the disease, discovered in the 1970s, can kill between 25 and 90 percent of those infected (SN: 2/11/19). Previously, people could only be helped by supportive therapies, such as replacing lost fluids, Saphire says. "But this approval means Ebola is now a treatable disease."

Inmazeb was evaluated along with three other experimental treatments for Ebola in a clinical trial conducted in Congo in 2018 and 2019 amid the second largest outbreak of the disease (SN: 8/12/19). During the trial, 33.8 percent of people treated with Inmazeb died after 28 days, compared with 51 percent of people who received different treatment.

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The drug consists of three different monoclonal antibodies, made by humans designed to mimic those produced naturally during an immune response. One smells of Ebola virus structures that allow it to infiltrate human cells, while the other two recruit immune cells to eliminate the virus and infected cells.

Saphire, who leads a research consortium focused on studying antibody treatments for Ebola, says that given the two-pronged approach to the drug to fight the virus, "the Regeneron cocktail is exactly the kind of complementary approach our research has predicted. which would be more effective ”(Regeneron Pharmaceuticals is one of the main financial supporters of the Society for Science & the Public, which publishes Science News).

Inmazeb, which is delivered intravenously, has been used to treat patients in the ongoing Ebola outbreak in the Congo under compassionate use protocols. The new FDA approval will remove regulatory hurdles, says Saphire, which allows local doctors and health care groups like Doctors Without Borders to more easily obtain the drug from U.S. national reserves and deploy them to affected areas.

In July, Regeneron and the U.S. Advanced Biomedical Research and Development Authority announced an agreement whereby the company would produce Inmazeb for a national reserve in the next six years.



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