New Delhi (NVI): The US Food and Drug Administration (FDA) has given full approval for the use of antiviral drug ‘Remdesivir’ to treat COVID-19 patients in hospitals.
The Gilead Sciences Inc’s antiviral drug, sold under the brand name ‘Veklury’, cut the recovery time on average by five days during clinical trials.
“Veklury is the first treatment for COVID-19 to receive FDA approval,” the FDA said in a statement, the BBC reported.
Earlier this month, the World Health Organization (WHO) said Remdesivir had little to no effect on patient’s survival, which was based on its own study – but the drug manufacturer Gilead rejected the findings of the trial.
Moreover, Remdesivir had been authorised for emergency use only in the United States since May. It was recently given to President Donald Trump after he tested positive for COVID-19.
In the statement, the FDA said that the antiviral drug Veklury (remdesivir) 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.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen Hahn said in a statement.
“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,” he added.
The FDA further said that, 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.
As per one of the studies “the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group”.
Meanwhile, Europe and other countries such as Canada also have granted temporary approval for the use of remdesivir.
Remdesivir, which is administered by an injection, was one of the first drugs to show relative promise in shortening the time to recovery in some COVID-19 patients. It can be administered to adults and children over the age of 12 who weight more than 40 kilos (88 pounds) who require hospitalization for the treatment of COVID-19, the illness caused by the coronavirus, the FDA said.
The drug can only be given to patients in a hospital or equivalent setting and the emergency approval has been granted for its use on pediatric patients under the age of 12 weighing at least 3.5 kilos, it added.
The FDA approval is based primarily on a US trial of 1,062 patients that found Remdesivir speed up patient’s recovery time by five days compared with placebo. However, the study failed to show a statistically significant benefit in reducing deaths.