Benzinga | Jun 25, 2021 07:45AM EDT

Jazz Pharmaceuticals Announces FDA Orphan Drug Exclusivity For Xywav Oral Solution

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity for Xywav(tm) (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. Xywav is an oxybate product with a unique composition of cations resulting in 92% less sodium -- or approximately 1,000 to 1,500 mg/night -- than sodium oxybate at the recommended dosage range of 6 to 9 grams.1

FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS associated with narcolepsy, stating that "the active moiety, oxybate, was previously approved as Xyrem(r) (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 of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated."

"We are pleased that FDA has recognized the greater safety of Xywav by virtue of the greatly reduced chronic sodium burden. This action is consistent with FDA's long-established position on the benefits of reducing daily sodium intake," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "As a long-time leader in sleep medicine, we are well aware of the many challenges facing patients living with narcolepsy, including the greater risk of cardiometabolic comorbidities, including obesity, hypertension, diabetes and hypercholesterolemia.2,3,4,5 We are encouraged that FDA recognized the benefits of reducing sodium in a chronic medication for these patients. We advanced low-sodium Xywav from concept to commercial availability, demonstrating Jazz's maturing capabilities and delivering a much-needed medicine for patients in critical need."

The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for Xywav began on July 21, 2020, the date of FDA approval.