US FDA authorizes emergency use of Gilead’s COVID-19 drug remdesivir

WASHINGTON: Gilead Science Inc’s antiviral drug remdesivir was granted emergency use authorization by the US Food and Drug Administration for COVID-19 on Friday, clearing the way for broader use of the drug in more hospitals around the United States.
During a meeting in the Oval Office of the White House with President Donald Trump, Gilead 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 ... hospitalized 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.
The FDA authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation.
Gilead said the federal government will coordinate the donation and distribution of remdesivir to hospitals in cities hardest hit by COVID-19. Citing the drug’s limited supply, the company said hospitals with intensive care units and other hospitals that the government deems most in need will receive priority.
Countries around the world are reeling from the novel coronavirus. There are more than 1 million cases and over 63,000 people have died in the United States, where much of the country is on lockdown to contain the spread of the virus.
Gilead said on Wednesday the drug, which is given by intravenous infusion, had helped improve outcomes for patients with COVID-19, the respiratory disease caused by the novel coronavirus, and provided data suggesting it worked better when given earlier in the course of infection.
Data released this week from a National Institutes of Health trial showed that remdesivir reduced hospitalization stays by 31% compared to a placebo treatment.
Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and 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.
The recent clinical data has raised hopes remdesivir might be an effective treatment for the novel coronavirus that has infected more than 3 million people and killed over 225,000 worldwide.
A draft study abstract released inadvertently by the World Health Organization (WHO) 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.