FDA OKs Gilead’s Bid to Drop Extended Monopoly on Virus Drug (1)

The FDA granted Gilead’s request to drop extended monopoly rights on potential Covid-19 treatment remdesivir, an agency spokesman said.

Dropping that special status, known as an orphan drug designation, means Gilead Sciences Inc. will waive an extra seven years of exclusivity for the medication. Orphan drug designations are intended to spur companies to develop treatments for rare conditions affecting 200,000 people or less that wouldn’t be economical otherwise.

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” the company said Wednesday afternoon in a statement. “Recent engagement with ...