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Gilead's Request To Revoke Remdesivir Orphan Designation Reflects Pandemic Pressures

 
• By Brenda Sandburg

Two days after US FDA granted remdesivir orphan status for treatment of COVID-19, Gilead told the agency it is unnecessary. EMA says it would not grant orphan drug designation to a COVID-19 treatment.

Never Mind.
Gilead asks FDA to revoke orphan drug designation for remdesivir for COVID-19 treatment

In a surprising reversal, Gilead Sciences Inc. announced on 25 March that it has asked the US Food and Drug Administration to rescind the orphan drug designation for remdesivir for treatment of COVID-19, which the agency granted two days earlier. By the end of the day, the agency had processed the request and withdrawn the designation.

Several groups had issued calls for the FDA to revoke the designation after it became public, arguing that the number of people in the US infected with COVID-19 would soon surpass the 200,000 limit for being deemed an orphan disease

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