Gilead asks to rescind special status for potential virus drug

Gilead Sciences has asked US regulators to revoke “orphan drug” status for its potential treatment for coronaviruses, after being criticized by activists for abusing a drug-only rare disease process.

The company’s unusual turnaround on its potential coronavirus candidate Remdesivir comes just two days after Gilead revealed that it was granted status by the United States Food and Drug Administration. The drug maker said on Wednesday that it is giving up all the benefits of the status – which include substantial tax incentives and price controls for at least seven years in a de facto monopoly.

The Financial Times reported on Tuesday that activists had criticized the designation, calling it a “morbid calculation” in the face of a rapidly spreading pandemic. Orphan drugs are intended for diseases affecting up to 200,000 people in the United States. In the United States, almost 60,000 people are infected with a coronavirus, but this number is probably underestimated. Globally, more than 436,000 people have been infected.

“Gilead is confident that it can maintain an accelerated deadline to request a regulatory review of remdesivir, without the designation of an orphan drug,” the company said on Wednesday.

Activists criticized the timing of the move, which was released hours after the drug maker said it would limit some of its supplies for compassionate purposes.

“Gilead admitted not having applied for orphan status until early March, after it was clear it was a pandemic,” said Jamie Love, founder of the intellectual property advocacy group Knowledge Ecology International.

“Gilead’s decision may solve a problem, but we do not know what other drugs will qualify for orphan status. The FDA made the mistake, and the FDA procedures must be corrected, “added Love.

The FDA’s decision to grant orphan drug status angered Congress, where some US lawmakers have expressed concern that society may use it to make remdesivir unaffordable for many coronavirus patients.

Before Gilead backed down, Patty Murray, the longest serving Democrat on the Senate health committee, said the FDA’s decision had raised “some flags,” adding that she was considering pushing the agency. to explain why she made this decision.

Many analysts believe that remdesivir, originally developed to treat Ebola, is one of the best bets to treat Covid-19. Animal studies have also shown that it works against other coronaviruses.

Data from a small study using the drug to treat Covid-19 patients in China is expected to be released in the coming weeks. Large trials of hundreds of patients have been launched, among others, by the World Health Organization and the National Institutes of Health in the United States.

Gilead’s turnaround follows AbbVie, a US pharmaceutical company that makes a combination of HIV drugs that are also tested for the virus, has surrendered all intellectual property rights to the combination worldwide, paving the way low-priced generics to flood the market.

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