The US FDA on Thursday granted full approval to the antiviral drug remdesivir as a treatment for Covid-19 patients, after conditional authorization was given in May.
Remdesivir is an antiviral medication that is given intravenously has been approved by Food and Drug Administration for every corona patient who is hospitalized. It works by blocking the virus’s ability to make more copies of itself.
After the outbreak of corona, in May, the drug had received emergency use authorization (EUA), was not approved but was still being used during the public health crisis. The drug was approved after its makers Gilead provided more information to the FDA on the medication’s effectiveness and safety.
“This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19,” says Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center hailing the approval who was among the first to treat patients from the Diamond Princess Cruise ship with remdesivir and runs one of the drug’s clinical trials.
“Remdesivir shortens the recovery time by 5-7 days, provides 50% faster clinical improvement, prevents patients’ progression to mechanical ventilation, and is associated with a 45% mortality reduction in the first two weeks of disease. These are real and meaningful benefits to our patients”, he said.
FDA in its announcement statement said, “for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of Covid-19 requiring hospitalization.”
“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 hospitalized 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”.