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Investing.com — Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) announced after the bell Monday that the Food and Drug Administration has granted Orphan Drug Exclusivity for its Xywav oral treatment for idiopathic hypersomnia in adults.
It is the second time Orphan Drug Exclusivity has been granted for the medication after it was previously granted in treating cataplexy, or excessive daytime sleepiness, in patients seven years of age and older with narcolepsy.
Xywav will have seven-year market exclusivity for idiopathic hypersomnia from its FDA approval on August 12, 2021.
The Orphan Drug Designation program is devised to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients per year.
“Prior to the approval of Xywav no treatments were approved for people living with this debilitating and unique sleep disorder, so we are very proud of how we advanced the medicine from concept to commercial availability and are encouraged that FDA has recognized Xywav’s impact by granting ODE for the treatment of idiopathic hypersomnia,” said Robert Iannone, executive vice president of research and development and chief medical officer of Jazz Pharmaceuticals.
Monday saw the company’s shares rise 2.83%, to $131.01 per share. In after-hours trading, the stock has risen 3.83%, to $136.03.
