Jazz Pharmaceuticals now has exclusive rights for the next seven years to market and produce Xywav for the treatment of idiopathic hypersomnia in adults.
Jazz announced on Monday that the U.S. Food and Drug Administration (FDA) granted them Orphan Drug Exclusivity (ODE), a drug designation program that incentivizes companies to advance the development of drugs that treat conditions affecting 200,000 or fewer U.S. patients annually.
Xywav, composed of calcium, magnesium, potassium, and sodium oxybates, has already received ODE for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
“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,” Robert Iannone, MD, chief medical officer of Jazz Pharmaceuticals, says in a statement.
“We believe FDA’s decision also recognizes the importance of Jazz’s commitment to developing differentiated new medicines where others have not to benefit people with limited treatment options,” says Iannone, executive vice president of research and development.
Xywav for idiopathic hypersomnia was approved with multiple dosing options, offering healthcare providers the opportunity to cater to each individual patient’s needs. The majority of clinical trial participants found optimal doses on a twice-a-night regimen.
