Recently, Jazz Pharmaceuticals announced that the FDA has accepted Xywav oral solution for the treatment of adult patients with idiopathic narcolepsy as a supplementary new drug application for substantive review.
The FDA granted the sNDA a priority review, and has designated the "Prescription Drug User Fees Act" (PDUFA) target action date of August 2, 2021.
If approved, Xywav will be the first and only drug in the United States to treat adult patients with IH.
In July 2020, Xywav was approved by the US FDA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy (narcolepsy) patients 7 years and older.
IH is a chronic neurological disease characterized by excessive sleepiness, uncontrollable sleep requirements, or daytime sleepiness that lasts for at least 3 months, even when sleep is adequate or prolonged at night.
According to US insurance claims data, there are more than 37,000 adult patients diagnosed with IH, but there may be more undiagnosed.