FDA Approves Jazz Pharmaceuticals’ Xywav for Idiopathic Hypersomnia

Jazz Pharmaceuticals’ Xywav oral solution is the first treatment to be approved for adults with idiopathic hypersomnia.

The FDA Wednesday approved Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia (IH), marking the first approved indication for adults with IH.

Already approved for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy, phase 3 findings presented at the 2021 American Academy of Neurology Annual Meeting showed that Xywav provided clinically meaningful improvements in symptoms of IH compared with placebo, including in the primary endpoint of Epworth Sleepiness Scale (P < .0001) and secondary endpoints of Patient Global Impression of Change (P < .0001) and Idiopathic Hypersomnia Severity Scale (P < .0001).

"The clinical program for Xywav has demonstrated that this lower-sodium oxybate is an effective therapy for the treatment of IH," said Yves Dauvilliers, MD, director of the Sleep Disorders Centre at the Gui de Chauliac Hospital in Montpellier, France, and lead investigator of the phase 3 study. "Having an FDA-approved treatment option that manages symptoms associated with IH, including excessive daytime sleepiness and severe sleep inertia, is a significant step forward for patients."

The approval of Xywav follows previous Priority Review and Fast Track designations by the FDA for the treatment of IH, which is characterized by chronic excessive daytime sleepiness and sleep inertia.

Often mistaken for other more common conditions such as narcolepsy, IH was shown in a prior survey to be misdiagnosed by more than half of participating health care providers, with 95% noting that patients were frustrated with their current disease management. An estimated 37,000 people in the United States have been diagnosed with IH.

“We are excited that with today's approval Xywav will become the first and only medicine indicated to treat IH, a unique medical condition that can have significant effects on the lives of those diagnosed with the condition," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “We are proud to build on our leadership in sleep medicine and, with this approval, are expanding beyond our Xywav narcolepsy indications to bring this treatment to adults living with IH who currently have no FDA-approved options available.”

Jazz Pharmaceuticals noted plans to make Xywav available to patients with IH later this year following Risk Evaluation and Mitigation Strategies implementation.