FDA approves first-ever idiopathic hypersomnia treatment

The US Food and Drug Administration on Thursday approved a new indication for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia (IH) in adults.

IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav, from Jazz Pharmaceuticals (Nasdaq: JAZZ), is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

Ireland-headquartered Jazz, whose shares rose about 1% to a session high of $146.66 yesterday, plans to make Xywav available to patients with idiopathic hypersomnia later this year following Risk Evaluation and Mitigation Strategies (REMS) implementation. An estimated 37,000 people in the USA have been diagnosed with IH and are actively seeking healthcare.