Please ensure Javascript is enabled for purposes of website accessibility

Gilead Asks the FDA to Rescind Orphan Drug Designation for Remdesivir as a Treatment for COVID-19

By Brian Orelli, PhD - Mar 25, 2020 at 6:10PM

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

U.S. cases of COVID-19 may exceed the maximum for the designation.

Gilead Sciences (GILD 0.53%) has asked the Food and Drug Administration to rescind the orphan drug designation it was awarded for remdesivir as a treatment for COVID-19, the disease caused by the new coronavirus.

On Monday, Gilead got some backlash on Twitter for announcing the orphan drug designation, because the designation is reserved for drugs that treat diseases that affect fewer than 200,000 patients in the U.S.

Gilead applied earlier this month, when there were only a handful of cases in the U.S., but the number of confirmed cases in the U.S. has jumped to over 62,800, according to Johns Hopkins University. Given the delay in testing, many experts think the actual number is much higher than the number of confirmed cases.

Patient and a doctor in protective clothing with a sign about an outbreak alert

Image source: Getty Images.

Orphan drug designation entitles a company to tax credits for qualified clinical trials, as well as a waiver of the fees companies pay to have their marketing applications reviewed by the FDA. Companies also get a waiver of the requirement to provide a pediatric study plan prior to the submission of the marketing application, which Gilead notes can take up to 210 days to review in normal circumstances.

Of course, these aren't normal circumstances, and Gilead is "confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation." The company noted that the agency has expedited reviews of regulatory requirements so far.

Gilead started two phase 3 clinical trials of remdesivir, which was originally developed for the treatment of Ebola, about a month ago. The studies are scheduled to enroll 1,000 patients total -- 400 patients with severe manifestations of COVID-19 in one study, and 600 patients with moderate manifestations in the other. The trials are testing five and 10-day regimens, and will measure progress through day 14, so data should be available fairly quickly after the last patient is enrolled in the study.

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, Inc. Stock Quote
Gilead Sciences, Inc.
GILD
$62.54 (0.53%) $0.33

*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
319%
 
S&P 500 Returns
112%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 06/29/2022.

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.