US FDA approves use of Gilead's remdesivir for hospitalised coronavirus patients

Henrietta Brewer
October 23, 2020

The US Food and Drug Administration on Thursday granted full approval to the antiviral drug remdesivir as a treatment for patients hospitalized with COVID-19, after conditional authorization was given in May.

President Donald Trump, who tested positive for the coronavirus early in October, was treated with remdesivir at a military hospital outside Washington, among other drugs.

However it has not been proven to significantly help moderately ill patients, and many doctors remain wary of using it in patients with less severe illness.


The FDA's formal approval comes just hours before the president's final debate with Democratic rival Joe Biden ahead of the Nov 3 presidential election. That study has not been reviewed by outside experts.

"The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources", ACTT-1 investigator Barry Zingman, MD, of the Albert Einstein College of Medicine and Montefiore Medical Center in New York City, said in a press release from drugmaker Gilead Sciences.

"The formal FDA approval doesn't change our (sales) estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval", said analyst Steven Seedhouse from investment bank Raymond James.


"The formal FDA approval doesn't change our (sales) estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval", Raymond James analyst Steven Seedhouse said in a research note, calling the prescribing guidelines and approval "pretty much a best case for Gilead", given the World Health Organization results questioning remdesivir's benefits.

In August, the company said it planned to produce more than 2 million treatment courses of remdesivir by the end of the year and anticipated being able to make "several million more" in 2021, adding it has increased the supply of the drug more than fiftyfold since January.

However, other treatments have received authorization for emergency use, though that approval can be revoked once the public health emergency sparked by the coronavirus pandemic is over. For patients younger than 12, the FDA will still allow the drug's use in certain cases under its previous emergency authorization. The FDA also has given emergency authorization to using the blood of survivors, and two companies are now seeking similar authorisation for experimental antibody drugs.


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