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FDA accepts sNDA for Xywav to treat with idiopathic hypersomnia with PDUFA date on 12 August 2021- Jazz Pharma

Read time: 1 mins
Published:13th Apr 2021
Jazz Pharmaceuticals plc announced that the FDA has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New Drug Application (sNDA) seeking approval for Xywav (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 III 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 <0.0001 and the key secondary endpoints of patient global impression of change (pgic) p-value><0.0001 and idiopathic hypersomnia severity scale (ihss) p-value><0.0001. the phase iii study results will be presented during the clinical trials plenary session of the 2021 american academy of neurology (aan) annual meeting on april 20, 2021, with an investor webcast to follow.>
Condition: Sleeping Disorders/Idiopathic Hypersomnia
Type: drug

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