PARIS, May 22, 2018 /PRNewswire/ --
FAST TRACK AND BREAKTHROUGH DESIGNATIONS BY THE FDA AND FIRST U.S. NARCOLEPSY PATIENTS INCLUDED IN AN EXPANDED ACCESS PROGRAM
Bioprojet is pleased to share the following announcement from their partner Harmony Biosciences, LLC (Harmony) who received Breakthrough Therapy and Fast Track designations for their investigational product, Pitolisant, from the U.S. Food and Drug Administration (FDA).
We remind you that Pitolisant is now marketed under the Tradename Wakix or in the process of commercialization in most European countries.
"We are very pleased to learn this news which means that U.S. patients with narcolepsy will benefit soon from this new therapeutic option, already available for European patients," said Bioprojet's co-founders, CEO, Jeanne-Marie Lecomte, and CSO, Jean-Charles Schwartz.
Pitolisant is an investigational medication in the U.S. that is not currently approved by the FDA. It received orphan designation by the FDA for the treatment of narcolepsy. Pitolisant is the first selective histamine H3-receptor antagonist/inverse agonist; it enhances the activity of histaminergic neurons in the brain, which function to improve a patient's wakefulness and inhibit attacks of cataplexy. It has been developed by Bioprojet which has marketed the product in Europe since its Approval by the European Medicines Agency in 2016. The receipt of Breakthrough Therapy and Fast Track designations for pitolisant allows Harmony to request a rolling submission from the FDA with the goal of obtaining approval to market this new medication in the U.S. in 2019. If approved, Pitolisant would represent the first new therapy in the U.S. in over a decade for the treatment of both excessive daytime sleepiness and cataplexy in patients with narcolepsy
Bioprojet is a pharmaceutical company headquartered in Paris, France. Its activity is focused on the design, synthesis and development of novel classes of drugs for unmet medical needs, such as Pitolisant (Wakix®). Bioprojet is commercially active in 7 western European countries through its own organization and commercially covering the rest of the world through distributors and licensees.