Gilead Sciences' investigational antiviral drug remdesivir has been saddled with high hopes as drugmakers search for a possible COVID-19 treatment. But after the FDA made the controversial decision to name remdesivir an orphan drug—a tag that comes with years of market exclusivity—Gilead bowed to critics' outrage and asked for an out.
Gilead has asked the FDA to rescind its newly granted orphan drug designation for COVID-19 candidate remdesivir following a wave of backlash over the decision, including pushback from presidential candidate Sen. Bernie Sanders of Vermont.
The drugmaker argued in a statement that it didn't require the FDA's tag to secure an expedited review for remdesivir as a treatment for COVID-19, making no mention of the seven-year market exclusivity that comes with that designation.
"Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation," the company said. "Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited."
Gilead said it applied for the designation in early March in part to waive its requirement to create a pediatric study plan prior to submitting an FDA application––a process it said could delay review by up to 210 days. Drugs with FDA's orphan tag receive seven-year market exclusivity that prevents generic challengers.
Critics worried that designating remdesivir as an orphan drug would allow Gilead to effectively set whatever price it chose for the therapy. On Wednesday, Sanders blasted the FDA's decision to designate remdesivir as an orphan drug, calling the move "truly outrageous."
“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."
Public Citizen applauded Gilead's decision Thursday, saying it was "outrageous" the drugmaker pursued the designation int he first place. The consumer group called on Gilead to commit to licensing remdesivir if it proves effective in treating COVID-19 through a "modest" royalty-based agreement.
But Cantor analyst Alethia Young said in a note to investors Thursday that the orphan drug backlash was overblown and that Gilead was likely attempting to preempt some of the public outrage it received despite it being "very clear that it does not have a commercial remdesivir strategy."
"We think that (Gilead) worried that this negative rhetoric around something that was never going to happen in the first place would be distracting during such a critical time to develop and try to bring this drug to market and to also remain focused on other key programs that can be revenue generating," Young wrote.
With confirmed and presumed cases of COVID-19 on the rise in the U.S., drugmakers are under the microscope to avoid accusations of profiteering amid a global pandemic.
On Monday, AbbVie reportedly gave up its global patent rights to HIV med Kaletra, hoping to avoid a possible shortage as the drug works its way through clinical trials as a treatment for COVID-19. The surprise move served to undercut the millions in revenue AbbVie might have secured if Kaletra proves an effective treatment.
Mylan, which makes a generic Kaletra, followed suit Wednesday, saying it would give up U.S. rights to its generic, allowing more competitors to jump in.
Hope has run high for remdesivir after small-scale studies in China reportedly showed efficacy in COVID-19 patients treated with the investigational candidate, which was originally developed to treat SARS.
Demand has run so high, in fact, that Gilead on Sunday announced it would temporarily halt emergency access to the drug, citing "overwhelming demand." Exceptions will be made to pregnant women and children under 18 with severe COVID-19, the disease caused by the novel coronavirus.
As the company works to process previously approved requests, it’s devising expanded access programs for widespread treatment use, pivoting away from the current individual patient pathway.
“This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” Gilead said. It added that these programs are under “rapid development” with regulators worldwide, though exact timelines remain unclear.