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Potential virus treatment granted rare disease status

WASHINGTON — The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with U.S. regulators, a status that can potentially be worth millions in tax breaks and competition-free sales.

What that specialty status will actually mean for the marketing or profitability of Gilead Science’s experimental drug remdesivir isn’t clear. The drugmaker did not immediately respond Tuesday to requests for comment.

Experts who have studied the so-called “orphan drug” program say the company’s request — and the Food and Drug Administration’s decision to grant it — seem inappropriate given the rapidly expanding threat of the viral outbreak.

A financial analyst, though, called Gilead’s request “pretty standard.”

The FDA granted the status on Monday, according to the agency’s website. If approved for coronavirus, Gilead Sciences would receive seven years of exclusive U.S. marketing for the drug and tax credits on its research and development costs.

Congress created the orphan drug program more than 35 years ago to encourage companies to develop drugs for niche diseases and conditions that might not otherwise be profitable. But since then, filing for orphan status has become a standard pharmaceutical industry tactic to extend the profitability of drugs and block competitors. Orphan drugs are also typically eligible for other special programs that speed up FDA reviews for approval.

The FDA defines a rare disease as one with fewer than 200,000 patients in the U.S. In a statement Tuesday, the agency said COVID-19 fit that criteria when the request was made.