On June 24, 2024, Harmony Biosciences announced FDA approval of its supplemental new drug application (sNDA) for pitolisant (WAKIX) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 and older with narcolepsy.
About pitolisant (WAKIX)
Pitolisant is a selective histamine 3 receptor antagonist/inverse agonist. It is marketed as WAKIX and was approved by the FDA in 2019 for the treatment of EDS in adult patients with narcolepsy. It was approved for the treatment of cataplexy in adults with narcolepsy in 2020.
With the latest approval, WAKIX is the first-and-only FDA-approved non-scheduled treatment option for EDS in children with narcolepsy.
According to the company’s press release, the FDA granted priority review of the sNDA based on results of a phase 3 multi-center, randomized, placebo-controlled study conducted by Bioprojet that evaluated the safety and efficacy of WAKIX in pediatric patients aged 6 to 18 years with narcolepsy with or without cataplexy.
About narcolepsy
Narcolepsy, a lifelong neurological disorder, disrupts normal sleep-wake cycles, causing patients to feel overwhelmingly tired or experience sudden episodes of muscle weakness known as cataplexy. With a prevalence of about one in 2,000 people, this often-undiagnosed condition can significantly impact daily activities, such as eating, walking and driving, highlighting the importance of recognizing and managing its symptoms.
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