Coronavirus: FDA approves Gilead's antiviral drug for Covid-19 patients

Remdesivir receives emergency use authorisation after White House officials claim it shows promising signs

An experimental antiviral drug from Gilead Sciences has been approved by the federal Food and Drug Administration as an emergency treatment for coronavirus patients.

Donald Trump and White House officials announced on Friday that 1 million vials of remdesivir will be sent to hospitals beginning next week.

The FDA's emergency use authorisation does not meet the same standards of review as a formal approval. The intravenous drug is approved for use in patients who have been hospitalised.

This week, Dr Anthony Fauci reported that early remdesivir trials showed "quite good news" following the release of results from the National Institute of Allergy and Infectious Diseases that showed patients who used the drug recovered four days faster than patients who didn't use the drug. The study has not been peer-reviewed.

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Dr Fauci said on Wednesday.

Gilead had initially developed the drug to treat Ebola patients but it was shown to be ineffective.

The company's CEO Daniel O'Day has said that remdesivir could be administered through an injection or an inhaler, but those methods could take months or years to develop.

Remdesivir is currently only administered through an IV, though Gilead predicts it could treat up to 1 million patients by the end of the year.

The president has hailed the drug as a "game changer" though health officials are wary of declaring it a success just yet.

Former FDA Commissioner Scott Gottlieb said the drug is a "beginning" but more trial results and reports will determine its efficacy.

He said: "Evolutionary, not revolutionary. Remdesivir appears active, may help some patients. ... We'll need better drugs and ultimately a vaccine. But this could help if used appropriately, especially if we also have antibody drugs by fall."

Controversial anti-malaria drugs chloroquine and hydroxychloroquine — which were touted by the president for several weeks as a coronavirus treatment — had previously received similar emergency use authorisation to treat Covid-19 patients, though the agency later warned against patients using the drug outside a clinical trial setting following reports that it could cause "serious heart rhythm problems" in some patients.

Nearly 65,000 people have died from illness related to the virus, according to Johns Hopkins University data, and the nation's positive diagnoses have reached more than 1 million, roughly one-third of global cases of Covid-19.