The FDA decision on Xywav in idiopathic hypersomnia is expected in the third quarter of 2021.
The FDA granted Priority Review to Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia (IH), which could become the first treatment to be approved for adults with the condition.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 12, 2021.
As a debilitating neurological sleep disorder characterized by chronic excessive daytime sleepiness and sleep inertia, IH can often be mistaken for other more common conditions such as narcolepsy.
In fact, a prior survey conducted by Jazz Pharmaceuticals and the Hypersomnia Foundation indicated that 57% of providers said they had personally misdiagnosed IH, with more than 90% also stating that physicians need more education about the condition.
“Leveraging emerging science and reinforcing what IH is, as well as how it is different from other conditions is critical to helping health care providers and people living with IH better understand the condition, how to recognize it through unique symptoms such as sleep inertia, and how to effectively manage it,” said Robert Iannone, MD, MSCE, executive vice president of research and development for Jazz Pharmaceuticals, in an email exchange with The American Journal of Managed Care®.
Already approved for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy, Jazz Pharmaceuticals submitted a supplementary new drug application (sNDA) to the FDA following positive top line results of its phase 3 study in adult patients with IH.
Presented recently at the 2021 American Academy of Neurology Annual Meeting, results indicated that Xywav met its clinically meaningful improvements in its primary endpoint of Epworth Sleepiness Scale (ESS) and secondary endpoints of Patient Global Impression of Change (PGIc) and Idiopathic Hypersomnia Severity Scale (IHSS).
Moreover, patients did worse when administered a placebo compared with Xywav for ESS (P < .0001), PGIc (P < .0001), and IHSS (P < .0001).
Xywav previously received a Fast Track designation by the FDA in September 2020 for the treatment of IH, which was then followed by a rolling submission granted by the FDA for the sNDA in December. If approved by the FDA, Jazz Pharmaceuticals plans to bring Xywav to market for US patients with IH in the fourth quarter of 2021.
Speaking further on education efforts for health care providers and patients, Iannone noted his organization’s continued role in spreading awareness about IH, which has been associated with decreased quality of life, impairment in work functioning, and an increased risk of motor vehicle accidents.
“We have long understood that sleep disorders can impact every facet of someone's life and are committed to leading the evolution of sleep medicine to offer better therapies,” said Iannone.