Remdesivir gets US FDA approval as COVID-19 treatment

(NewsNation Now) — The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s remdesivir, for the treatment of patients with COVID-19 requiring hospitalization.

The drug, which California-based Gilead Sciences is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

It had been authorized for use on an emergency basis since spring, and now has become the first drug to win full U.S. approval for treating COVID-19.

Gilead said it expects to meet global demand for the drug in October.

Remdesivir, previously granted emergency use approval to treat COVID-19, was one of the drugs used to treat U.S. President Donald Trump’s coronavirus infection.

The antiviral drug “works to stop replication of SARS-CoV-2,” which is the virus that causes COVID-19, Gilead said in a news release announcing the FDA approval.

The approval was based on three randomized controlled trials, including one recently published from the National Insitute of Allergy and Infectious Diseases. The three trials showed that remdesivir “significantly improved time to recovery as compared to placebo – by five days in the overall study population” and “seven days in patients who required oxygen support at baseline.”

“The speed and rigor with which we have reached this milestone reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance new treatment options for patients in the fight against COVID-19,” said Daniel O’Day, chairman and CEO.