• ENG

US gives full approval for antiviral drug remdesivir in COVID-19 treatment

US gives full approval for antiviral drug remdesivir in COVID-19 treatment
Earlier, remdesivir was approved for treatment of COVID-19 in approximately 50 countries, including India.

FDA grants full approval to remdesivir for COVID-19 treatment after trials showed that it cut the recovery time on average by five days.

Written by Jahnavi Sarma |Published : October 23, 2020 2:55 PM IST

US regulators have given full approval for the antiviral drug remdesivir to treat COVID-19 patients in hospitals. 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 in a statement, the BBC reported on Friday. However, the World Health Organization (WHO) said last week remdesivir had little to no effect on patients' survival. The WHO Solidarity trial found that remdesivir, the antiviral drug that's widely prescribed against COVID-19, has no substantial effect on mortality, initiation of ventilation or duration of hospital stay. The WHO said this was based on its own study - but the drug's manufacturer Gilead rejected the findings of the trial.

Remdesivir approved for use in patients 12 years and older

Remdesivir had been authorised for emergency use only in the US since May. 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".

Approval comes after trials prove efficacy

"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 that "the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group".

Also Read

More News

Remdesivir was part of WHO Solidiraty trial

For its Solidarity clinical trial, the WHO tested the effects four potential treatments of which remdesivir was one. But they also looked at malaria drug hydroxychloroquine, auto-immune drug interferon, and the HIV drug combination of lopinavir and ritonavir. WHO said that these drugs too have little or no effect on 28-day mortality. WHO discontinued hydroxychloroquine and lopinavir-ritonavir arms in July following the interim results. Dexamethasone, a low-cost steroid now widely used on COVID patients in intensive care in the UK, was not included in this study. The four drugs were tested with 11,266 adult patients in total, across 500 hospitals in more than 30 different countries. The results, which are yet to be peer-reviewed, suggested that none of these treatments had a substantial effect on mortality or on the length of time spent in hospital, the WHO said.

Earlier, remdesivir was approved for treatment of COVID-19 in approximately 50 countries, including India. The drug was pre-qualified by WHO. This drug had shown positive results in three other randomised, controlled clinical trials. In one large controlled trial in the US, it was seen that the drug brought down recovery time by about a third in severely ill, hospitalised adults with COVID-19, but was of little to help those with milder cases.

(With inputs from IANS)