Potential Covid drug registered

WASHINGTON, D.C.: The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with United States 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 socalled “orphan drug” program say the company’s request — and the Food and Drug Administration’s ( FDA) decision to grant it — seem inappropriate given the rapidly expanding threat of the viral outbreak.

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 US 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 US.

In a statement, the agency said the coronavirus disease 2019 or Covid-19 fit that criteria when the request was

made. There are more than 50,000 cases in the US but many more expected in the coming weeks and months.

The nonprofit Public Citizen group said in a statement that the US government should be “urgently concerned” with the affordability of remdesivir.

Gilead’s chairman and chief executive officer, Daniel O’Day has previously said the company has not discussed with any governments how much remdesivir will cost.