Earlier this month, Gilead Sciences submitted a request to the US Food and Drug Administration (FDA) to receive orphan status for remdesivir, an investigational antiviral, as a potential treatment for COVID-19. The FDA can grant the designation to treatments intended for diseases that affect fewer than 200,000 patients in the country.
Obtaining orphan drug designation for a treatment provides a number of benefits. For example, this specific status enables the owner to waive the requirement to provide a pediatric study plan prior to the submission of a New Drug Application; that review process can take as long as 210 days.
Last week, the company withdrew its request. In a public statement, a Gilead representative said that the company “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 withdrawal comes after a wave of comment from public officials, industry figures and other entities, criticizing Gilead for pursuing orphan status for the potential COVID-19 treatment. Sen. Bernie Sanders, current Democratic presidential candidate, accused the firm of “profiteering” and called on President Donald Trump to rescind the status.
“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,” Sanders said in a statement. “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 company statement indicates it recognizes the pressing need for development of effective COVID-19 treatments, adding its work to pursue such solutions will continue.
“Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic,” the statement added. “The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available.”
Last week, Gilead joined Novartis, GSK and other pharmaceutical firms in an initiative led by the Bill and Melinda Gates Foundation. The collaborative effort is intended to pool knowledge and resources to accelerate COVID-19 tests and treatments.