US FDA approves remdesivir, first drug to treat COVID-19 patients

Oct 23, 2020

Washington [US], October 23 : The United States Food and Drug Administration (FDA) has approved Remdesivir for the treatment of coronavirus, Al Jazeera reported citing a statement issued by Gilead Sciences, Inc.
According to the press release by the company, previously authorised by the FDA for only emergency use to treat COVID-19 patients, Veklury or Remdesivir is now the first and only approved COVID-19 treatment in the United States.
"This approval is based on three randomized controlled trials including the recently published, final results of the National Institute of Allergy and Infectious Diseases' (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients," Gilead Sciences, Inc said.
The drug was also recently touted by US President Donald Trump, whose physician confirmed he received it at Walter Reed National Military Medical Center as part of his own treatment for COVID-19 earlier this month, Al Jazeera said.
Last week, NHK World reported that the World Health Organisation (WHO) in its interim results of a clinical trial had said that Remdesivir has little or no effect in preventing death from COVID-19 or reducing time in hospital. The trial was carried out in more than 400 hospitals in 30 countries.
According to the latest update by the Johns Hopkins University, globally 41,536,126 people have tested positive for coronavirus and 1,134,981 deaths have been reported so far.