Gilead's remdesivir gets US emergency approval for Covid-19

Way cleared for broader use of drug in more hospitals around US; firm donating 1.5m vials

Singapore's National Centre for Infectious Diseases and general public hospitals are jointly participating in three global drug trials for remdesivir. PHOTO: AFP

WASHINGTON • Gilead Science's antiviral drug remdesivir has been granted emergency use authorisation by the US Food and Drug Administration (FDA) for Covid-19, clearing the way for broader use of the drug in more hospitals around the United States.

During a meeting in the White House with President Donald Trump, Gilead chief executive Daniel O'Day called Friday's move an important first step and said the firm was donating 1.5 million vials to help patients.

The donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.

Gilead said on Wednesday the drug, which is given by intravenous infusion, has helped improve outcomes for patients with Covid-19, and provided data suggesting it worked better when given earlier in the course of infection.

With many countries reeling from the coronavirus pandemic, interest in Gilead's drug has been high because there are currently no approved treatments or vaccines for Covid-19.

In Singapore, the National Centre for Infectious Diseases and general public hospitals are jointly participating in three global drug trials for remdesivir.

One trial is with the National Institutes of Health (NIH) in the US and two others are with Gilead.

Japan's Health Ministry has also begun a special approval process for remdesivir as a potential treatment for Covid-19, NHK reported.

The approval process could be completed in around a week, the public broadcaster said without citing anyone.

Doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.

"It's the first authorised therapy for Covid-19, so we're really proud to be part of it," FDA commissioner Stephen Hahn said during the meeting.

Data released last week from a trial by the NIH showed that remdesivir reduced hospitalisation stays by 31 per cent compared with a placebo treatment, but did not significantly improve survival.

Gilead did not immediately respond to a request for the price it plans to charge for the drug after its pledged donations are used up.

The Institute for Clinical and Economic Review, which assesses the effectiveness of drugs to determine appropriate prices, put the cost of producing a 10-day course of remdesivir at US$10 (S$14.15), but suggested that the price would hit US$4,500 based on patient benefits shown in clinical trials.

Remdesivir was previously available only for patients enrolled in clinical trials or those cleared to get the drug under expanded use and compassionate use programmes. Through Gilead's trials, more than 181 hospital locations around the world, including hospitals in 27 US states, have been administering the drug.

The FDA authorisation applies to patients hospitalised with severe Covid-19 who require oxygen supplementation. US Vice-President Mike Pence said the 1.5 million vials would start being distributed to hospitals from tomorrow.

More than 3.4 million people have been infected by the coronavirus worldwide and over 240,000 have died, according to the Worldometer pandemic data site. The US has the most cases and fatalities at more than 1.1 million and at least 65,700, respectively, with much of the country in lockdown to contain the spread of the virus.


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A version of this article appeared in the print edition of The Sunday Times on May 03, 2020, with the headline Gilead's remdesivir gets US emergency approval for Covid-19. Subscribe