US clears anti-viral drug for emergency use in coronavirus patients

Drug maker Gilead will donate to US hospitals 1.5 million vials of the drug Remdesivir, which data has shown can reduce hospitalisation stays by 31 per cent compared to a placebo treatment.

Previous known strains of human coronaviruses.

Previous known strains of human coronaviruses. Source: Cover Images

The antiviral drug Remdesivir has been granted authorisation for emergency use for COVID-19 cases by the US Food and Drug Administration.

During a meeting in the White House with President Donald Trump, Gilead Science Inc's Chief Executive Daniel O'Day called the move an important first step and said the company was donating 1.5 million vials of the drug to help patients.

"We're humbled by this being an important first step for ... hospitalised patients. We want to make sure nothing gets in the way of these patients getting the medicine, so we made a decision to donate about 1.5 million vials," he said.

Exterior view of Gilead Sciences Inc in Foster City, California.
Exterior view of Gilead Sciences Inc in Foster City, California. Source: EPA

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

The FDA authorisation applies to patients hospitalised with severe COVID-19 who require oxygen supplementation.

Gilead said on Wednesday that the drug, given by intravenous infusion, had helped improve outcomes for patients with COVID-19, the respiratory disease caused by coronavirus, and provided data suggesting it worked better when given earlier in the course of infection.

Data released from a National Institutes of Health has shown the drug can reduce hospitalisation stays by 31 per cent compared to a placebo treatment.

The recent clinical data has raised hopes Remdesivir might be an effective treatment for the novel coronavirus that has infected more than three million people and killed over 225,000 worldwide.

However, a draft study abstract released inadvertently by the World Health Organisation last week said remdesivir failed to improve patients' condition or reduce the pathogen's presence in the bloodstream. The drugmaker said the findings were inconclusive because the study was terminated early.

Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host's immune system.

Vice President Mike Pence said the 1.5 million vials would start being distributed to hospitals on Monday.

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3 min read
Published 2 May 2020 at 9:04am