Posted by Michael Wonder on 22 May 2018
Harmony Biosciences receives breakthrough therapy and fast track designations for pitolisant
21 May 2018 - Expanded access program for pitolisant is open and patients are being enrolled.
Harmony Biosciences today announced that it has received breakthrough therapy and fast track designations for its investigational product pitolisant from the U.S. FDA.
Harmony also announced today that the Pitolisant Expanded Access Clinical Evaluation (PEACE) program is open and patients are being enrolled. This is an open-label expanded access program intended to provide treatment with pitolisant to adult patients in the U.S. with excessive daytime sleepiness associated with narcolepsy with or without cataplexy.
