Gilead Requests Retraction of Orphan Designation for Remdesivir

Gilead Sciences has requested the U.S. FDA rescind orphan drug designation for remdesivir, a potential COVID-19 treatment, waiving all benefits associated with the designation.

The request comes amid growing concerns the specialty status could impact pricing and competitor products.

Orphan drug designation is given to investigational compounds intended to treat a rare disease, affecting fewer than 200,000 persons in the U.S., or a condition that has limited treatment options. Orphan drug status comes with certain benefits such as marketing exclusivity and waiver of prescription drug user fees, and certain testing requirements.

Remdesivir is an antiviral drug currently being evaluated in Phase III clinical trials as a potential treatment for severe and moderate manifestations of COVID-19.

Gilead recently suspended compassionate use access of remdesivir to patients with severe coronavirus due to overwhelming demand.

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