Posted by Michael Wonder on 23 Jan 2020
Jazz Pharmaceuticals submits new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy
22 January 2020 - Jazz Pharmaceuticals today announced the submission of a new drug application to the U.S. Food and Drug Administration on 21 January 2020 seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
The company redeemed its priority review voucher for the submission.
The submission is based on a Phase 3 global, double-blind, placebo-controlled, randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of JZP-258 in the treatment of cataplexy and excessive daytime sleepiness associated with narcolepsy.
