Gilead Withdraws Orphan Drug Designation Request for Remdesivir

In a surprise move driven by public outcry, Gilead has asked the FDA to rescind the newly granted orphan drug designation for remdesivir as a potential COVID-19 treatment.

The agency’s designation prompted a public outcry because the company would qualify for seven years of exclusivity and other commercial advantages if the drug was approved.

Gilead said it can maintain an expedited review timeline of the drug without it.