The United States Food and Drug Administration (FDA) plans to announce an emergency-use authorisation for remdesivir, a trial drug for the treatment of COVID-19.
Although the FDA has not yet approved any drugs for the treatment of the coronavirus, CNN quoted The New York Times as reporting that the authorisation could come as soon as Wednesday.
In a statement to CNN, the FDA said it was in talks with Gilead Sciences, the maker of remdesivir, about making the drug available to patients.
A government-funded study found that patients who took remdesivir recovered faster than patients who did not.
Federal officials are keen to provide any hope they can in a pandemic that has infected more than 1 million Americans and killed close to 60,000 of them.
The head of the National Institute of Allergy and Infectious Diseases (NIAID) was optimistic about the results.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Dr Anthony Fauci said at the White House during a meeting with President Donald Trump.
Results from the preliminary trial show remdesivir improved recovery time for coronavirus patients from 15 to 11 days.
That’s similar to the effect that the influenza drug Tamiflu has on flu. Tamiflu also doesn’t cure patients quickly, but can reduce how long they are sick.
Remdesivir is among several drugs being tested against Covid-19, but the NIAID trial is the first conducted according to rules aimed at gaining FDA approval.
About 1,090 people participated in the trial internationally, Fauci said, calling it “the first truly high-powered randomized placebo-controlled trial.”
But the World Health Organisation said it’s too early to comment on the remdesivir trial results released Wednesday.
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“Typically, you don’t have one study that will come out that will be a game-changer,” said Dr Maria Van Kerkhove, the WHO’s technical lead for the coronavirus response.
