Vanda Pharmaceuticals has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Now, following a lawsuit and a protracted back-and-forth with the U.S. regulator, the FDA has crushed Vanda’s bid.
Early this month, the FDA said it denied Vanda’s request for a hearing over the agency's prior complete response letter. Besides the hearing rejection, the decision “refuses approval” of the company's supplemental application for Hetlioz, according to a post in the Federal Register.
Separately, the company revealed Wednesday that the FDA also shot down Hetlioz's expansion bid in insomnia. In early February, the FDA alerted Vanda that it had identified shortcomings in the drug's insomnia application that "precluded discussion of labeling and postmarketing requirements/commitments," Vanda said in a release. Vanda said it's evaluating next steps.
Hetlioz snagged its first FDA green light in 2014 for a circadian rhythm condition known as non-24-hour sleep-wake disorder. In 2020, the drug scored another nod to treat kids and adults experiencing nighttime sleep disorders associated with the rare neurodevelopmental disorder Smith-Magenis syndrome.
When the FDA rejected Vanda's jet lag disorder application back in 2019, the agency specifically took issue with the way the company tried to show longer sleep durations in a small study of people who flew from the U.S. to the U.K.
Overall, 13 patients who received Hetlioz slept nearly three hours longer than the 12 in the control cohort, which failed to persuade the FDA.
Vanda ultimately disputed the decision and requested an FDA hearing in July of 2022. The company explained that the FDA “privately” agreed to the hearing but failed to published a notice in the Federal Register, which stonewalled the hearing process.
The company kicked things up a notch when it sued the agency in September 2022.
Meanwhile, with the prospect of new Hetlioz indications sidelined, Vanda has been busy beefing up its commercial portfolio in other areas.
Late last year, Vanda laid out $100 million to secure U.S. and Canadian rights to Johnson & Johnson’s multiple sclerosis (MS) med Ponvory. Beyond its 2021 nod in relapsing forms of MS, Ponvory also has the potential to treat certain inflammatory and autoimmune disorders like ulcerative colitis, Vanda said at the time.
Aside from Hetlioz and Ponvory, Vanda also markets the schizophrenia treatment Fanapt.
Editor's note: This story has been updated with details about Vanda's new Complete Response Letter for Hetlioz in insomnia.