Gilead Withdraws Application for Orphan-Drug Status

By Tom Burton

Gilead Sciences Inc. withdrew its application to get orphan-drug status for its investigational coronavirus drug remdesivir, after public-interest groups and Vermont Sen. Bernie Sanders accused the company of improperly capitalizing on the national epidemic.

Gilead received the special status just this week from the Food and Drug Administration. The status would have conferred seven years of monopoly as well as tax benefits, but the company dropped the special status after objections were raised.

Orphan-drug status was created by law to apply to rare diseases affecting fewer than 200,000 people, where drugmakers might not have a financial incentive to develop medications.

Mr. Sanders, who is running in the Democratic presidential primary, called the special status "truly outrageous" and had called on the Trump administration to reverse the special status for the drug. The public-interest group Public Citizen said that if the drug proves useful against the new coronavirus, "the world cannot afford to have one manufacturer maintain a monopoly over it."

Gilead didn't immediately respond to a request for comment.

Write to Tom Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

March 25, 2020 17:26 ET (21:26 GMT)

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