BioPharma, Policy

Gilead asks FDA to rescind rare disease designation for Covid-19 drug amid criticism

A day after receiving orphan drug designation for remdesivir that gave it a fast track to approval and lengthened its market exclusivity, Gilead is requesting the FDA to rescind the designation. Critics had previously charged that the designation could make the drug less affordable.

One of the largest companies developing a drug to treat the novel coronavirus, for which it received an orphan drug designation from the Food and Drug Administration, is now asking the FDA to take that designation back amid a backlash against the agency’s decision to grant it Tuesday.

Foster City, California-based Gilead Sciences said Wednesday that it had submitted a request to the FDA to rescind the designation for remdesivir, which is currently in Phase III trials as a potential treatment for Covid-19, the disease caused by the SARS-CoV-2 virus. Early results for the drug are expected in April.

Shares of Gilead were down about 4.6% on the Nasdaq in the hours after the news broke.

Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” a company statement read. “Recent engagement with regulatory agencies has demonstrated that submissions and review related to remdesivir for the treatment of COVID-19 are being expedited.”

Gilead applied for the designation earlier this month and received it from the FDA on Tuesday. The FDA grants orphan drug designation to medicines affecting fewer than 200,000 people in the U.S. While that is technically true at the moment for Covid-19 – which as of Wednesday had been diagnosed in 55,568 people in the U.S. – Gilead said it “recognizes the urgent public health needs posed by the COVID-19 pandemic.”

The designation would allow for seven years’ data exclusivity for the drug instead of the usual five and a waiver in the requirement to conduct a pediatric study plan before applying for approval, a process that can take up to 210 days.

The announcement follows widespread criticism of Gilead’s securing the orphan drug designation. Investigative journalism outlet The Intercept noted, for example, that it could limit the drug’s affordability.

Some advocacy groups were pleased to learn of the news.

“Gilead’s desperate retreat in the face of public pressure is fantastic news for patients and families across the country who were shocked to hear that the massive pharmaceutical company was being allowed to game the system to protect their profits during a public health crisis,” said Eli Zupnick, a spokesperson for Patients Over Pharma, in a statement.

Gilead is one of numerous companies developing drugs to potentially treat Covid-19. Regeneron Pharmaceuticals and Sanofi are running a Phase III study of the drug Kevzara (sarilumab), while Vir Biotechnology said Wednesday that it had selected two drug candidates to enter into clinical trials, which it expects to happen this summer. Remdesivir was originally developed for Ebola virus, but it has gained interest as a potential treatment for SARS-CoV-2 due to its preclinical activity against other coronaviruses and anecdotal accounts of activity in patients.

Photo: Tomsmith585, Getty Images