Gilead Asks FDA to Revoke Orphan Drug Status for Potential Coronavirus Drug

By Reuters Staff

March 26, 2020

(Reuters) - Gilead Sciences Inc said on Wednesday it had requested the U.S. Food and Drug Administration to rescind the "orphan drug" status for its experimental drug, remdesivir, seen as one of the more promising potential treatments for coronavirus, sending its shares down 4.4%.

The orphan drug status provides a seven-year market exclusivity period, as well as tax and other incentives for drug companies developing treatments for rare diseases that affect fewer than 200,000 people.

Senator Bernie Sanders has criticized U.S. President Donald Trump's administration for granting Gilead the seven-year exclusivity, and the drugmaker has also faced flak from health advocates. (

The drugmaker said it was confident of maintaining an expedited timeline for seeking regulatory review of remdesivir, without the orphan drug designation.