JAZZ - Jazz completes rolling submission for Xywav marketing approval in idiopathic hypersomnia

Jazz Pharmaceuticals (JAZZ) announces the completion of the rolling submission for the supplemental New Drug Application ((sNDA)) to the U.S. FDA for the marketing approval of Xywav oral solution for the treatment of adult patients with idiopathic hypersomnia.Xywav received Fast Track designation by the FDA in September last year for the treatment of idiopathic hypersomnia. If approved, Xywav will be the first and only approved treatment in the U.S. for adults with idiopathic hypersomnia, Jazz said.Jazz said that it is planning to bring the treatment option to patients in Q4 of this year, subject to FDA approval.Idiopathic hypersomnia is a debilitating illness characterized by chronic and disabling excessive daytime sleepiness that can significantly affect social, school and occupational functioning.

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Jazz completes rolling submission for Xywav marketing approval in idiopathic hypersomnia