Gilead Sciences Inc. unveiled topline data on 1 June from a Phase III study of its antiviral remdesivir in moderately ill COVID-19 patients that increase the evidence suggesting the drug can offer a treatment benefit, but at the same time raise as many questions as they answer.
The data from the 584-patient SIMPLE study add to findings from a placebo-controlled study run by the US National Institute for Allergy and Infectious Diseases and Gilead’s own Phase III SIMPLE-study in severely ill patients indicating that the nucleotide analog can help patients already sick with the novel coronavirus. (Also see "Gilead's Remdesivir Results Encouraging, Safety Brings Skepticism" - Scrip, 29 April, 2020.) The drug is approved to treat the virus in Japan and is available in the US under a Food and Drug Administration emergency use authorization (EUA); it still needs to go through the standard FDA approval process for US market access beyond the duration of the EUA
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