Jazz Pharmaceutical’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults has been granted US Food and Drug Administration (FDA) approval.
Idiopathic hypersomnia is a debilitating neurological sleep disorder characterised by chronic excessive daytime sleepiness.
This FDA approval is based on its Phase III study, in which Xywav demonstrated statistically significant and clinically meaningful differences in the primary endpoint of Epworth Sleepiness Scale and secondary endpoints of Patient Global Impression of Change and the Idiopathic Hypersomnia Severity Scale.
“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.
“The clinical programme for Xywav has demonstrated that this lower-sodium oxybate is an effective therapy for the treatment of idiopathic hypersomnia,” added 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 III study.
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.
Xywav was approved in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.
Dublin-based Jazz Pharma plans to make Xywav available to patients with idiopathic hypersomnia later this year following Risk Evaluation and Mitigation Strategies (REMS) implementation.