RARE Daily

Gilead Asks FDA to Rescind Remdesivir Orphan Drug Designation

March 25, 2020

Rare Daily Staff

Gilead Sciences has asked the U.S. Food and Drug Administration to rescind the Orphan Drug designation the agency granted for its experimental antiviral remdesivir for the treatment of COVID-19.

The request to rescind the designation comes just two days after it was granted as Gilead faced intense criticism for trying to profit from the global COVID-19 pandemic. The company said it is waiving all benefits that accompany the designation.



Orphan Drug designation is granted by the FDA to drugs and biologics intended to treat rare disease of conditions that affect fewer than 200,000 patients in the United States. Among the benefits of orphan drug designation, this status results in a waiver of the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review, according to Gilead.

But Gilead said in a statement that it is confident it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.

At the time the designation was granted, the CDC said there were 33,000 reported cases of COVID-19. But the number of reported cases of the highly infectious viral disease is growing exponentially as more testing becomes available.


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