U.S. explores emergency-use approval for Gilead drug after study found it helped recovery from COVID-19

Federal health regulators are exploring whether to approve the emergency use of the Gilead Sciences drug remdesivir in serious COVID-19 patients, after U.S. government researchers reported the therapy helped the patients recover faster.

Federal health regulators are exploring whether to approve the emergency use of the Gilead Sciences drug remdesivir in serious COVID-19 patients, after U.S. government researchers reported the therapy helped the patients recover faster. The National Institute of Allergy and Infectious Diseases said Wednesday that preliminary results indicate hospitalized COVID-19 patients taking remdesivir in the institute's study had a quicker recovery than patients taking placebo. The reported benefit was moderate, however, with remdesivir patients recovering in 11 days, or 4 days faster than the placebo group. Also on Wednesday, a separate study in China posted negative results for the drug. The researchers urged more testing, however, because their trial was stopped early due to problems recruiting subjects as the pandemic slowed there. Gilead is in active discussions with FDA about securing emergency authorization for remdesivir, which would allow the company to work with the government to directly ship the drug to hospitals with the greatest need. Gilead expects to have manufactured 1.5 million doses by the end of May, or up to 210,000 treatment courses, assuming that most patients are treated for 5 days, and the company will donate the supply to hospitals and doctors free of charge, said Gilead CEO Daniel O'Day.