image credit: The U.S. FDA / Wikimedia

In rare move, Gilead gives up ‘orphan’ status for experimental coronavirus drug

Gilead has asked the Food and Drug Administration to rescind a special regulatory status for its experimental coronavirus drug, but not before stirring up a controversy that had critics accusing the company of manipulating a law designed to spur research into therapies for rare diseases.

So-called Orphan Drug status, which the FDA granted Monday, would have limited competitors from filing applications for generic versions of Gilead’s drug for seven years. In addition, Gilead would have qualified for tax credits to defray the costs of developing the drug, called remdesivir and currently in testing as a treatment for COVID-19.

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