FDA Grants Gilead's Remdesivir Emergency Use Authorization for COVID-19
The U.S. Food and Drug Administration (FDA) approved Gilead's remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.
The EAU came barely 48 hours after results from the NIAID trial that showed COVID-19 patients receiving remdesivir had a 31% faster time to recovery than the placebo group. As BioSpace reported this week, patients who received remdesivir recovered about four days faster than those on placebo, a median of 11 days versus 15 days, respectively. Survival benefit was not statistically significant, according to the results, about 8% compared to 11.6% for the placebo group. But, the results do suggest a survival benefit.
In its announcement this afternoon, the FDA noted that until this EAU, there had been no medicines approved by the FDA that have been considered safe and effective to treat people in the hospital who have COVID-19. Under the dosing provisions of the EAU, remdesivir is delivered intravenously one time per day for up to 10 days.
“Remdesivir may help decrease the amount of the coronavirus in your body. This may help you to get better faster,” the FDA said in its brief announcement.
EAU is a declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The FDA made its decision to provide the EAU based on the available scientific evidence that shows remdesivir meets “certain criteria” in efficacy and safety to treat COVID-19 patients during the pandemic. The EUA for remdesivir is in effect for the duration of the COVID-19 declaration or until such time as the EUA is revoked. In its announcement, the FDA reminded the public that Gilead’s remdesivir “has not undergone the same type of review as an FDA-approved or cleared product.”
In addition to the NIAID results, Gilead Sciences also reported results from its own open-label trial of remdesivir. The company’s Phase III SIMPLE trial evaluated a 5-day and 10-day dosing regimen of the drug. Trial results showed that patients receiving the 10-day regimen had similar improvement in clinical status compared to patients on the 5-day course. In the trial, the time to clinical improvement for 50% of patients was 10 days in the 5-day cohort and 11 days in the 10-day cohort.
“This outcome has positive implications for our supply of remdesivir. Our teams have been ramping up production since January, working within all the constraints that come with such a lengthy and complex manufacturing process. Our existing supply, including finished product ready for distribution as well as materials in the final stages of production, amounts to 1.5 million individual doses,” Gilead Sciences Chief Executive Officer Daniel O’Day, said in an open letter following the announcement of the trial results.
O’Day added that the company estimated this would be 140,000 treatment courses based on a 10-day treatment duration. Following the positive reports from the trial, O’Day said it was scaling its manufacturing efforts in order to prepare for need from a potential EAU, which has since been awarded. He said the company is working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production.
According to the Johns Hopkins COVID-19 Dashboard, more than 3.3 million people have been infected with COVID-19, including 1.09 million in the United States. While more than one-third of infected patients have recovered, the disease has killed 237,180 people worldwide, including 64,324 in the United States.