Jazz Pharmaceuticals pushes to expand label on Xywav; FDA eyes October for decision on Seagen's latest ADC
Eight and a half months since its last OK for Xywav, Jazz Pharmaceuticals has won priority review for a new indication with the drug.
The FDA granted the expedited inspection Monday morning, Jazz announced, as the biotech looks to expand Xywav into adult idiopathic hypersomnia patients. Regulators have set a PDUFA date of Aug. 12.
Back in July 2020, Xywav notched its first approval to treat cataplexy and excessive daytime sleepiness associated with narcolepsy in patients older than 7. At the time, the drug joined Sunosi and Xyrem in the company’s sleeping disorder-related portfolio.