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Law360 (October 22, 2020, 10:19 PM EDT ) The U.S. Food and Drug Administration on Thursday gave the green light to Gilead's antiviral drug remdesivir for treatment of hospitalized COVID-19 patients that are at least 12 years old, marking the agency's first full approval for a drug to treat COVID-19.
The drug, called Veklury, can be administered to those who weigh at least 40 kilograms, or about 88 pounds, in a hospital or health care setting, the FDA said.
"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic," FDA Commissioner Stephen M. Hahn said in a release.
Gilead also said results from clinical trials show that the drug helps patients hospitalized with COVID-19 recover more quickly.
Earlier this month, however, the World Health Organization said that the world's largest randomized control trial on COVID-19 therapeutics has generated conclusive evidence that remdesivir and other drugs "appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients."
Remdesivir, which was used to treat Ebola, got emergency use authorization to treat suspected or laboratory-confirmed COVID-19 cases in adults and children hospitalized with "severe disease," from the FDA in May.
In March, Gilead was granted orphan drug designation for remdisivir — a designation that would've given the company a seven-year monopoly on the treatment. But the company backed down and abandoned the designation following harsh backlash from public health groups, as well as Sen. Bernie Sanders, I-Vt.
Sanders said in a statement at the time that it was "not the time for profiteering in the pharmaceutical industry."
"Now is the time to bring our scientists together to develop and produce the best treatment for the coronavirus as quickly as possible," Sanders said.
Gilead had spent months evaluating the effectiveness of the drug. It was among a large group of companies attempting to develop a coronavirus vaccine. GeoVax Inc. and BravoVax Co. Ltd., as well as Regeneron Pharmaceuticals Inc. and Inovio Pharmaceuticals Inc., have also been working to develop a vaccine.
Later in May, Gilead announced that it struck deals with Mylan and other generic companies to make and sell its experimental remdesivir for 127 countries, drawing criticism from a consumer advocacy group that the arrangement "picks winners and losers" and that remdesivir should be in the public domain.
In a press release at the time, Gilead said that it had signed nonexclusive licensing deals with five generic makers based in India and Pakistan to manufacture remdesivir for "nearly all low-income and lower-middle-income countries as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access."
The companies — Mylan, Cipla Ltd., Ferozsons Laboratories Ltd., Hetero Labs Ltd. and Jubilant Life Sciences Ltd. — can set the prices for their own generic versions of remdesivir, Gilead said.
--Additional reporting by Hailey Konnath and Tiffany Hu. Editing by Jay Jackson Jr.
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