The approval of Veklury (remdesivir) was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19, the FDA said.
The US Food and Drug Administration (FDA) said Veklury, the drug’s brand name, 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.
Remdesivir had been authorised for emergency use only in the US since May.
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 (about 88 pounds) for the treatment of Covid-19 requiring hospitalisation”.
The move comes a week after the World Health Organization (WHO) said remdesivir has little or no effect on patients’ survival.
The WHO said this was based on its own study – but the drug’s manufacturer Gilead rejected the findings of the trial.
Download The Economic Times News App to get Daily Market Updates & Live Business News.