Gilead rescinds FDA designation for potential coronavirus treatment

Get all the latest news on coronavirus and more delivered daily to your inbox.  Sign up here.

Continue Reading Below

Gilead Sciences on Wednesday asked the U.S. Food and Drug Administration to rescind the orphan status designation given to its drug remdesivir, an antiviral medicine that is being tested as a potential treatment for the coronavirus.

“Gilead has submitted a request to the U.S. 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,” the company said in a statement.

TESLA CEO ELON MUSK PLEDGES CORONAVIRUS VENTILATOR PRODUCTION

Orphan status, which is intended to incentivize treatments for rare diseases affecting fewer than 200,000 people, was granted to Gilead on Monday.

CLICK HERE TO READ MORE ON FOX BUSINESS

The designation sparked criticism because it is unlikely that coronavirus would fit the rare disease criteria in the United States.

The designation comes with a number of benefits, including a seven-year monopoly on sales. It would have control over pricing and there were concerns some individuals would not be able to afford it.

CVS, OTHER PHARMACIES SHIPPING PRESCRIPTIONS FOR FREE DURING CORONAVIRUS PANDEMIC

Independent Vermont Sen. Bernie Sanders, who is seeking the Democratic nomination to run for president in November, accused the company of putting profits above human life.

Gilead said on Wednesday that it is confident it can maintain its accelerated timeline to meet regulatory review without the designation.

GET FOX BUSINESS ON THE GO BY CLICKING HERE