Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc is a global biopharmaceutical company focused on developing medicines for patients with rare diseases. The company has a diverse portfolio of medicines for epilepsies, cancers, and sleep disorders. Its lead marketed products are approved in various countries. Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution was approved by the FDA in July 2020 and launched in the U.S. in November 2020 for treating cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients aged seven and older. It was also approved by the FDA in August 2021 for treating idiopathic hypersomnia (IH) in adults and launched in the U.S. in November 2021. Xywav contains 92% less sodium than Xyrem®. Xywav is also approved in Canada for treating cataplexy in narcolepsy patients. Epidiolex® (cannabidiol) oral solution was approved by the FDA and launched in the U.S. in 2018. It is indicated for treating seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients one year of age or older. In the EU and Great Britain (marketed as Epidyolex®) and other markets, it is approved for adjunctive treatment of seizures associated with LGS or DS, with clobazam (EU and Great Britain only), in patients 2 years of age and older, and for adjunctive treatment of seizures associated with TSC in patients 2 years of age and older. Ziihera® (zanidatamab-hrii) was approved by the FDA in November 2024 via accelerated approval and launched in the U.S. in December 2024 for treating adults with previously treated, unresectable or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC), as detected by an FDA-approved test.