Gilead Asks FDA to Rescind Orphan Drug Status
Gilead has asked the US Food and Drug Administration to rescind the orphan drug designation it was granted for remdesivir, an investigational antiviral for the treatment of COVID-19, according to a statement from the company.
This would waive all benefits that come along with orphan drug designation, including tax breaks, waived FDA fees, and 7 years exclusivity.
Gilead said in the announcement that they are confident they can maintain an expediated regulatory review timeline.
The announcement that remdesivir was granted orphan drug designation drew backlash from a number of activists, including Senator Bernie Sanders, who believed the 7-year market exclusivity would allow the drugmaker to set whatever price is it wanted for the potentially life-saving therapy.
“Now is not the time for profiteering in the pharmaceutical industry,” Sanders said in a statement. “Now is the time to bring our scientists together to develop and produce the best treatment for the coronavirus as quickly as possible.”
The US Food and Drug Administration has granted the experimental coronavirus treatment remdesivir (Gilead Sciences) orphan drug designation.
On Sunday, Gilead said requests for compassionate use of the drug had overwhelmed their system and they could no longer keep up on fulfillment.
Compassionate use is a program that allows individuals outside of clinical trials to request use of experimental treatments.
The company is currently working on an expanded access program for remdesivir in COVID-19 treatment. No new individual compassionate use requests will be accepted until the new program is set up.
“This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide, and may vary by region based on local laws and regulations,” said Gilead in a statement.
Currently, remdesivir is not approved for any indication.