
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
Already approved for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy, phase 3 findings
"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
Often mistaken for other more common conditions such as narcolepsy, IH was shown in a prior
“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.
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