The US FDA has recognised seven years of ODE for Xywav in June 2021 to treat cataplexy or excessive daytime sleepiness in narcolepsy patients


US FDA grants exclusivity for Jazz’s Xywav. (Credit: Steve Buissinne from Pixabay.)

Jazz Pharmaceuticals has received the US Food and Drug Administration (FDA) Orphan Drug Exclusivity (ODE) for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution to treat idiopathic hypersomnia.

The company said that it is the second exclusivity for the drug, following FDA ODE for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients, aged seven years and above.

Xywav is a lower-sodium oxybate, which has been recognised for seven years of market exclusivity in this indication, by the FDA in June last year.

Jazz is the first company to obtain FDA approval for idiopathic hypersomnia.

Jazz Pharmaceuticals research and development executive vice president and chief medical officer Robert Iannone said: “Prior to the approval of Xywav, no treatments were approved for people living with this debilitating and unique sleep disorder.

“We are very proud of how we advanced the medicine from concept to commercial availability and are encouraged that FDA has recognised Xywav’s impact by granting ODE for the treatment of idiopathic hypersomnia.

“We believe FDA’s decision also recognises the importance of Jazz’s commitment to developing differentiated new medicines where others have not to benefit people with limited treatment options.”

Xywav was approved to treat idiopathic hypersomnia with multiple dosing options, allowing healthcare providers to customise the treatment based on patient needs.

Idiopathic hypersomnia is characterised by excessive daytime sleepiness, resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness.

Primary symptoms of the disease include confusion, irritability and severe sleep inertia or sleep drunkenness, and prolonged difficulty in waking up with frequent re-entries into sleep.

According to the US FDA, Xywav is clinically superior to Xyrem (sodium oxybate) to treat cataplexy or EDS associated with narcolepsy.

Also, the differences in the sodium content of the two products will be clinically meaningful in reducing cardiovascular morbidity in eligible patients, said the FDA.