USBN Q2 2018

US BUSINESS NEWS / Q2 2018 11 Harmony Biosciences Receives Breakthrough Therapy and Fast Track Designations for Pitolisant g “The expanded access program for pitolisant provides physicians in the U.S. with an opportunity to gain clinical experience with this first-in-class investigational product that works through the histaminergic system to improve wakefulness and inhibit attacks of cataplexy,” said Michael Thorpy, M.D., Professor of Neurology at Albert Einstein College of Medicine, Director of the Sleep-Wake Disorders Center at Montefiore Medical Center in New York, and Principal Investigator on the EAP for pitolisant. “I am pleased that Harmony Biosciences is making this program available while working on the NDA, as the data suggest that pitolisant could represent a new treatment option which is much needed for our patients with narcolepsy.”