Jazz boasts several exciting products in its pipeline or that are currently being evaluated by health regulators.
First, the company submitted a New Drug Application (NDA) for JZP-258 to the U.S. Food and Drug Administration (FDA) in January. JZP-258 is a potential treatment for cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.
Narcolepsy, a chronic sleep disorder that affects about one in 2,000 people in the U.S., is severely under-diagnosed: Up to 50% of those with this condition have not been diagnosed. Furthermore, narcolepsy is associated with other conditions, such as hypertension and cardiovascular disease. For those reasons, Jazz has high hopes for JZP-258.
There are about 30,000 cases of SCLC in the U.S. per year. The company said: "There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved." Jazz is expecting an answer from the FDA in mid-August, and if approved, Lurbinectedin could help the company decrease its top-line exposure to Xyrem.