Posted by Michael Wonder on 14 Feb 2019
Harmony Biosciences announces file acceptance of its new drug application for pitolisant
12 February 2019 - FDA grants priority review of the pitolisant new drug application.
Harmony Biosciences announced today that the U.S. FDA has accepted for filing the new drug application (NDA) for its investigational product, pitolisant, and has granted priority review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness and/or cataplexy in adult patients with narcolepsy. Harmony’s goal is to obtain FDA approval to market pitolisant in the U.S. in 2019.
The NDA submission is based on results from the clinical development program in narcolepsy, which included over 300 patients, some of whom were treated for up to five years. It also included safety data in over 1500 patients across multiple patient populations.
