US FDA approves Remdesivir for COVID-19 treatment amid WHO stance

By Rahul Vaimal, Associate Editor
  • Follow author on
Remdesivir from Gilead
Representational Image

American government agency Food and Drug Administration (FDA) which reviews, approves and regulates medical products in the country gave its absolute permission for the use of Gilead Sciences Inc’s antiviral drug Remdesivir for treating patients hospitalized with COVID-19. 

With approval, Remdesivir becomes the first only drug approved for treating patients infected by the novel coronavirus.

The US-based research-based biopharmaceutical company stated that it is currently meeting real-time demand for Remdesivir, sold under the brand name Veklury, in the US. The firm expects to meet the global demand for the drug by the end of October.

Earlier, the US FDA has granted emergency use authorization of the drug which in fact was one of the medications used by doctors to treat U.S. President Donald Trump during his recent bout with the coronavirus infection.

The drug became the standard of care for severe COVID-19 victims across the globe after a recent 1,062-patient study published in the New England Journal of Medicine showed that it reduced hospital stays by five days.

Last week, the World Health Organization opposed Gilead Sciences’ claim about its antiviral drug stating that its international trial of COVID-19 therapies found that Remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival.

Expressing its disappointment on the WHO study, the drug maker remarked that “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Remdesivir”.

“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design”. the drugmaker added.