The United States Food and Drug Administration (FDA) has approved Remdesivir for the treatment of coronavirus patients in hospitals.
According to the press release by the company, previously authorised by the FDA for only emergency use to treat COVID-19 patients, Veklury, the drug’s brand name 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.
It was recently given to President Donald Trump after he tested positive for Covid-19. He has since recovered.
In the statement, the FDA said the drug was approved on Thursday “for use in adult and paediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of Covid-19 requiring hospitalisation”.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic,” said FDA Commissioner Stephen Hahn
The regulator said its decision was supported by the analysis of data from “three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe Covid-19”.
One of the studies showed that “the median time to recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for the placebo group”.
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…Read more>>