US regulators have authorised the use of antiviral drug remdesivir for emergency treatment for COVID-19 cases.
The move clears the way for the intravenous drug to be distributed to doctors and administered to patients with severe symptoms, such as low blood oxygen or needing breathing assistance with a mechanical ventilator.
During a meeting in the White House with US 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.
Gilead did not immediately respond to a request for the price it plans to charge for the drug after those donations are used up.
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.
Gilead’s investigational antiviral for the treatment of COVID-19 receives @US_FDA Emergency Use Authorization. This more readily enables treatment of hospitalized patients with severe COVID-19 disease in the United States. Read more: https://t.co/p4LR0RM7sI. pic.twitter.com/4kg9oDQPRq
— Gilead Sciences (@GileadSciences) May 1, 2020
Data released from a National Institutes of Health trial showed that remdesivir reduced 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.