Gilead requests remdesivir Orphan Drug designation be rescinded
US biotech Gilead Sciences (Nasdaq: GILD) said on Wednesday that it has submitted a request to the US Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation.
Advocates have voiced concern that the FDA's decision to grant the Orphan status paves the way for Gilead to charge a high price for remdesivir, and could keep lower-priced generic versions of the med off the market for several years.
According to US media reports, which The Pharma Letter was unable to confirm as of this publication, the FDA has agreed to Gilead’s request and has withdrawn the designation.
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