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Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Idiopathic Hypersomnia

Published: 2021-04-12 11:45:00 ET

Final FDA decision anticipated by August 12

Phase 3 study results to be presented during AAN Annual Meeting Clinical Trials Plenary Session on April 20

Company to host investor webcast to review Phase 3 data on April 20 at 12:30 PM ET

DUBLIN, April 12, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New Drug Application (sNDA) seeking approval for XywavTM (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia. The sNDA will be filed by the FDA on April 13, 2021 and a PDUFA goal date for an FDA decision has been set for August 12, 2021.

Jazz submitted to FDA the clinical study report for the Phase 3 study of Xywav in a double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of Xywav in adult patients with idiopathic hypersomnia in December 2020 under rolling review, and completed the rolling submission of the sNDA in February 2021. The trial met its primary endpoint of clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) p-value

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.