Pitolisant Granted Breakthrough Therapy and Fast Track Designations by FDA
There is great news about a possible treatment option for narcolepsy and excessive daytime sleepiness! Harmony Biosciences, LLC, announced that the Food and Drug Administration (FDA) had granted “Breakthrough Therapy” and “Fast Track” designations for its investigational product, pitolisant.
This medication 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 inhibits attacks of cataplexy.
Receiving these two designations from the FDA will provide Harmony Biosciences with the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited review by the FDA. The goal is to obtain approval to market this new medication in the US in 2019.
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Date Created: May 22nd, 2018
Last Updated: December 8th, 2020
