FDA approves first COVID-19 treatment

Oct. 23, 2020

The U.S. FDA approved Gilead's antiviral drug Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization, making it the first drug for COVID-19 to receive the FDA nod.

The approval was granted for use in adult and pediatric patients 12 years of age and older — which means it does not include the entire population that had been authorized to use Veklury under the Emergency Use Authorization (EUA) originally issued in May. As such, the agency revised the EUA to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg (7.7 lbs) to less than 40 kg (88 lbs) or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

Remdesivir, which attacks a specific enzyme in several RNA viruses and was previously tested against Ebola, was thrust back into the headlines after it was revealed that President Trump received it following his positive COVID diagnosis.

The FDA approval comes despite last week's interim results from the WHO Solidarity Therapeutics Trial that found remdesivir to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients. But the remdesivir Solidarity findings conflicted with findings from the NIAID sponsored ACTT-1 trial — the results of which were cited in the FDA approval notice. NIAID's randomized, double-blind, placebo-controlled clinical trial evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. It found that the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference.

Gilead has been ramping up production of Veklury. "By increasing our internal manufacturing capacity, expanding our external manufacturing network and refining processes to shorten the production timeline, we will have enough Veklury supply to treat all clinically appropriate patients globally next week," said Gilead's CMO Merdad Parsey in an open letter on the drugmaker's website.

Read the FDA press release