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DUBLIN, Aug. 12, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.1 The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following Risk Evaluation and Mitigation Strategies (REMS) implementation.
"We are excited that with today's approval Xywav will become the first and only medicine indicated to treat idiopathic hypersomnia, 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. "Xywav is a meaningful treatment for patients as demonstrated by the statistically significant results from the Phase 3 clinical trial. 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 idiopathic hypersomnia who currently have no FDA-approved options available. This milestone exemplifies our patient-focused R&D strategy and internal development capabilities, and underscores oxybate as a key growth opportunity for Jazz. With this launch we will have achieved our goal of five product launches in two years."
Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness). In addition to excessive daytime sleepiness, symptoms may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent reentries into sleep, confusion and irritability), a core symptom of idiopathic hypersomnia, as well as prolonged, non-restorative nighttime sleep, cognitive impairment, and long and unrefreshing naps.2,3,4,5 An estimated 37,000 people in the U.S. have been diagnosed with IH and are actively seeking healthcare.6
"The clinical program for Xywav has demonstrated that this lower-sodium oxybate is an effective therapy for the treatment of idiopathic hypersomnia," said Yves Dauvilliers, M.D., 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 idiopathic hypersomnia, including excessive daytime sleepiness and severe sleep inertia, is a significant step forward for patients. Xywav fulfills an unmet need for those diagnosed with this sleep disorder, offering them management of their debilitating symptoms."
"Idiopathic hypersomnia can have a significant impact on the social, educational and occupational functioning of people living with the condition. Today's FDA approval is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder," said Diane Powell, board chair and chief executive officer of the Hypersomnia Foundation. "Our mission and values have consistently centered around supporting patients and scientific discovery and this announcement truly provides a sense of hope for those living with idiopathic hypersomnia."
Xywav received Fast Track designation by the FDA in September 2020 for the treatment of idiopathic hypersomnia and was granted Priority Review designation as part of the supplemental New Drug Application (sNDA) acceptance in April 2021. This milestone marks the second FDA approval for Xywav since it was first approved in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.
This FDA approval is based on the global Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study that demonstrated the efficacy and safety of Xywav for the treatment of idiopathic hypersomnia in adults. In the study, Xywav demonstrated statistically significant and clinically meaningful differences compared to placebo in change in the primary endpoint of Epworth Sleepiness Scale score (p-value
