Please ensure Javascript is enabled for purposes of website accessibility

FDA Authorizes Gilead's Remdesivir for COVID-19

By Jim Crumly – May 1, 2020 at 6:21PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

A temporary authorization for emergency use during the pandemic follows two successful clinical trials.

The U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to Gilead Sciences (GILD 0.53%) to use its investigational antiviral drug remdesivir to treat COVID-19. President Trump made the announcement in the Oval Office along with Gilead Chief Executive Officer Daniel O'Day, and the FDA released a letter confirming the authorization.

Remdesivir hasn't been formally approved to treat any disease, but today's action by the FDA authorizes it for temporary use during the pandemic to treat hospitalized patients with severe COVID-19.

Vials of drugs on a manufacturing line

Image source: Getty Images.

The FDA decision was based on a review of top-line data from two clinical trials. In a placebo-controlled phase 3 trial  conducted by the National Institute for Allergy and Infectious Diseases, 1,063 critically ill patients receiving remdesivir had an average recovery time of 11 days, compared with 15 days in the placebo group. Those receiving the drug also had a lower mortality rate, although the mortality result was not proven with statistical significance. Patients in Gilead's own Simple-1 trial showed improvement as well, but that trial was for comparing two different durations of treatment and wasn't placebo-controlled.

Gilead is donating its entire current supply of the drug at no cost, which amounts to enough to treat 140,000 patients, assuming a course of treatment lasting 10 days. The biotech company is racing to ramp up manufacturing capacity and has set a goal of producing 500,000 treatment courses by October and a million by December. The Simple-1 study, though, suggested that a 5-day course of treatment produced similar results as a 10-day course, so Gilead now believes it will be able to treat far more patients than it thought when it set those goals.

Jim Crumly owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Gilead Sciences Stock Quote
Gilead Sciences
GILD
$86.21 (0.53%) $0.45

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
349%
 
S&P 500 Returns
115%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 11/30/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.