Via Financial Times

Gilead Sciences is asking US regulators to rescind “orphan drug” status for its potential coronavirus medicine, after it was condemned by activists for abusing a process reserved for drugs for rare diseases in the face of a rapidly spreading pandemic.

The company’s unusual U-turn on its potential coronavirus candidate remdesivir comes just two days after Gilead disclosed it had been granted the status by the US Food and Drug Administration. The drugmaker said on Wednesday that it was waiving all benefits of the status — which include significant tax incentives and control over prices for at least seven years in a de facto monopoly.

On Tuesday the Financial Times reported that activists had slammed the designation, calling it “morbid calculus” in the face of a rapidly-spreading pandemic. Orphan drugs are intended for diseases affecting up to 200,000 people in the US. Almost 60,000 people are infected with coronavirus in the US, but the number is likely to be an underestimate. Globally, more than 436,000 people have been infected.

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” the company said on Wednesday.

Activists had criticised the timing of the move, which was disclosed hours after the drugmaker said it would be limiting some of its compassionate-use supplies.

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

“Gilead’s decision can fix one problem, but we don’t know what other drugs will qualify for orphan status. The FDA made the mistake, and the FDA procedures need to be fixed,” added Mr Love.

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The FDA’s decision to grant orphan drug status had prompted anger in Congress, where some US lawmakers expressed concern that the company could use it to make remdesivir unaffordable to many coronavirus patients.

Before Gilead made its reversal, Patty Murray, the most senior Democrat on the Senate health committee, said the FDA decision had raised “some concerning flags”, adding that she planned to push the agency as to why it had made the determination.

Many analysts believe remdesivir, originally developed to treat Ebola, is one of the best bets for treating Covid-19. Studies in animals have also shown it is successful 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 started by the World Health Organization and the US National Institutes of Health, among others. 

Gilead’s U-turn comes after AbbVie, a US pharma company that makes a combination of HIV drugs that are also being tested against the virus, waived all intellectual property rights on the combination worldwide, paving the way for lower-priced generics to flood the market.