JAZZ - Jazz Pharma reports Orphan Drug exclusivity for Xywav oral solution

Jazz Pharmaceuticals (JAZZ) announces that the FDA has recognized seven years of Orphan Drug Exclusivity for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness ((EDS)) in patients 7 years of age and older with narcolepsy.The FDA also published its summary of clinical superiority findings for Xywav, stating that "the active moiety, oxybate, was previously approved as Xyrem (sodium oxybate) for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy."According to FDA, "Xywav (calcium, magnesium, potassium, and sodium oxybates) is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem."The FDA's summary also stated that the differences in the sodium content will be clinically meaningful in reducing cardiovascular morbidity. The seven-year market exclusivity for Xywav began on July 21, 2020, the date of FDA

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Jazz Pharma reports Orphan Drug exclusivity for Xywav oral solution