Sam Boughedda

Investing.com — Jazz Pharmaceuticals PLC (NASDAQ) 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.

This is the second occasion Orphan Drug Exclusivity was granted to the medication. It had previously been granted to treat cataplexy or excessive daytime sleeping in patients older than seven with narcolepsy.

Xywav, which was approved by the FDA on August 12, 2021 will enjoy seven years of market exclusivity in idiopathichypersomnia. 

Orphan Drug Designation is designed to encourage the development and testing of medicines that can treat conditions that only 200,000 patients in the United States each year.

“Prior the approval 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’s stock price rose 2.83% to $131.01 a share. After-hours trading saw the stock rise 3.83% to $136.03.