That emergency authorization allows doctors to use the drug on hospitalized pediatric patients weighing between 3.5 kilograms (not quite 8 pounds) and 40 kilograms or hospitalized pediatric patients less than 12 years of age who weigh at least 3.5 kilograms. "It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the US that is available for all appropriate patients in need", they said.
The approval of Veklury was supported by the agency's analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
The FDA also issued a new emergency use authorisation on Thursday for remdesivir to treat hospitalised paediatric patients under age 12 who weigh enough to receive an intravenous drug.
However, Gilead immediately refuted the claim, saying that the WHO's study did not go through peer review, a procedure required for a medical journal publication.
Gilead's shares on the New York Stock Exchange jumped four percent soon after the announcement. A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug failed to prevent deaths in patients with COVID-19.
As previously reported, clinical trials of remdesivir have yielded mixed results for people with moderate or severe COVID-19.
KOLD In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States. WHO chief scientist Soumya Swaminathan said the U.S. FDA drug regulator does not appear to have taken the results of the global health body's study into account in giving approval. "Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group", stated the release.
The company said Veklury has regulatory approvals or temporary authorizations in about 50 additional countries.
The company is also developing an inhaled version of the drug that might be used outside a hospital setting, if approved. How it worksRemdesivir, which is administered by an injection, was one of the first drugs to show relative promise in shortening the time to recovery in some coronavirus patients.