JAZZ - FDA grants 'Priority Review' status to Jazz Pharmaceuticals' Xywav

Jazz Pharmaceuticals (JAZZ) announces that the U.S. FDA has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New Drug Application ((sNDA)) seeking approval for Xywav oral solution in adult patients with idiopathic hypersomnia.The health regulator has set an action date of August 12, 2021 for the sNDA.Jazz submitted the clinical study report for the Phase 3 study of Xywav to the FDA in December 2020 under rolling review, and completed the rolling submission of the sNDA in February 2021.The late-stage trial tested the treatment in a double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of Xywav in adult patients with idiopathic hypersomnia.The Phase 3 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.

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FDA grants 'Priority Review' status to Jazz Pharmaceuticals' Xywav