Rubber stoppers are placed onto filled vials of the drug remdesivir at a Gilead manufacturing site in the United States. | Gilead Sciences via APThe FDA on Thursday approved Gilead's coronavirus drug remdesivir — making it the only Covid-19 treatment to win full approval from U.S. regulatorscontrolled trials that showed remdesivir can reduce the length of hospital stays and the likelihoodrun by the National Institutes of Health, found that the drug could reduce the risk of death, however.
risk of death or length of hospitalization. The agency did not mention the WHO trial in its risk-benefit assessment for remdesivir. Merdad Parsey, Gilead's chief medical officer, said in an open letter Thursday that the data from the WHO trial "does not negate other study results," like those from the NIH trial.to review drugs prior to approval if there are questions about a treatment's efficacy or safety, did not do so for remdesivir.in adults and children over age 12 who are hospitalized with Covid-19.
The agency gave the drug an emergency-use authorization in May after preliminary data from the government trial, run by NIH's National Institute of Allergy and Infectious Diseases, showed that remdesivir cut the length of hospital staysSweetening the deal: As part of its approval, the FDA awarded Gilead a priority review voucher that it can use or sell to other companies to speed the review of another drug. Remdesivir qualified for the voucher because the agency considers it a medical countermeasure to a material threat — in this case, the virus.: Multiple, international late-stagethe safety and efficacy of remdesivir, known commercially as Veklury, in different patient populations, formulations, and in combination with other therapies.
The new hydroxychloroquine? Can we trade the 60 million doses of hydroxychloroquine from the Navarro National Stockpile for 100 doses of remdesivir?
Pity it doesn't work
Who profits?
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