Following Outcry, Gilead Sciences Seeks to Rescind Orphan Drug Designation for COVID-19 Drug

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A day after it was announced remdesivir had received Orphan Drug designation for treatment of COVID-19 from the U.S. Food and Drug Administration, Gilead Sciences submitted a request for the regulatory agency to rescind that offer after an outcry was raised over the potential for exclusivity for the experimental pandemic treatment.

In addition to the request to rescind the designation, which would have granted the company market exclusivity for seven years, Gilead said it is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited, the company said in a brief statement. Stock prices have fallen more than 4% since the announcement.

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Remdesivir is an antiviral drug that is currently in two late-stage trials for the treatment of COVID-19. The medication has been studied as a potential treatment for Ebola, Marburg, MERS and SARS. MERS and SARS are both caused by coronaviruses that have at least some similarities to the coronavirus causing COVID-19.

The company initially sought the designation earlier this month, a standard practice among drugmakers focused on the development of a drug that will treat a disease with fewer than 200,000 patients in the United States. Globally, there are more than 400,000 cases of COVID-19, the disease caused by the novel coronavirus that was declared a pandemic by the World Health Organization and about 55,000 in the United States.  In its announcement, Gilead said it recognizes the “urgent public health needs” posed by the pandemic and is working to advance the development of remdesivir as quickly as possible for this indication.

The award of Orphan Drug status for the experimental remdesivir was met with some outrage as much of the nation continues to remain in self-quarantine as part of an effort to “flatten the curve” of infection rates. Sen. Bernie Sanders, an outspoken opponent of high-priced prescription drugs, called it “outrageous” that the FDA would grant the status to Gilead Sciences. He said millions of dollars of taxpayer money have gone into the development of the anti-viral drug and added that while the pandemic rages, “now is not the time for profiteering in the pharmaceutical industry.”

“The Trump Administration must rescind this corporate giveaway to Gilead and make any treatment and vaccine free for everybody,” Sanders said in a statement. “When Jonas Salk developed the polio vaccine 65 years ago, he understood the tremendous value it would have for all of humanity, and he refused to patent it. Right now, we must put human life above corporate profit. We cannot give pharmaceutical corporations a monopoly on treatments that could save millions of people during this crisis.”

The receipt of and sudden request to rescind the Orphan Drug designation followed the company’s announcement over the weekend that Gilead Sciences planned to temporarily suspend individual compassionate use requests for remdesivir due to “overwhelming demand.” Gilead said it is in the process of transitioning from individual compassionate use requests to expanded access programs. Doing so will “both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” the company said. Gilead said it is attempting to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials.

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