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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

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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.

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