Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
Along with giving up the designation, Gilead said it’s waiving all benefits that come with it, including tax credits, seven years of market exclusivity and a waiver of the requirement to provide a pediatric study plan prior to submitting a new drug application. That requirement could slow the rush to get a new drug approved in an emergency situation, as it can take up to 210 days to review a pediatric study plan, according to the company.
In announcing its decision today, Gilead said it’s “confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan drug designation.” Its recent engagement with regulators has demonstrated that submissions and review relating to remdesivir as a COVID-19 treatment are being expedited, it added.
“Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic,” it said. “The company is working to advance the development of remdesivir as quickly as possible.”
Gilead requested the orphan drug designation early this month when about 500 COVID-19 infections had been confirmed in the U.S. and about 110,000 cases had been reported worldwide. The orphan drug status is granted to drugs that are being developed to treat diseases affecting fewer than 200,000 patients in the U.S.
When the FDA granted the designation this week, there were more than 43,600 COVID-19 cases in the U.S. And as of today, the World Health Organization is reporting more than 413,000 cases in 197 countries, with 18,433 deaths worldwide. While the number of cases in the U.S. would still qualify remdesivir for orphan drug status, the fear is that the number could escalate into the millions – thus the backlash.