Japan Approves First-in-Class Treatment for Narcolepsy and OSA-Related Excessive Daytime Sleepiness

Key takeaways:

• Japan’s Ministry of Health, Labour and Welfare granted approval for pitolisant (WAKIX) to treat excessive daytime sleepiness associated with obstructive sleep apnea syndrome and narcolepsy.
• The oral medication is the first histamine H3 receptor antagonist/inverse agonist approved for these conditions in Japan and is not classified as a controlled substance.
• The approval is backed by domestic Phase 3 clinical trials and international studies evaluating its efficacy in patients with narcolepsy and obstructive sleep apnea.

Japan’s Ministry of Health, Labour and Welfare has granted approval for WAKIX (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS) in patients receiving treatment for airway obstruction, as well as for narcolepsy (type 1 and 2, with and without cataplexy).

The medication, licensed to Viatris Inc for the Japanese market, is the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications. WAKIX is an orally administered drug that modulates the brain’s sleep-wake pathways and is not classified as a controlled substance. It also holds an orphan drug designation in Japan for narcolepsy.

“As Japan’s first approved histamine H3 receptor antagonist/inverse agonist for these conditions, WAKIX offers a much-needed novel treatment option for patients,” says Philippe Martin, chief R&D officer at Viatris, in a release. “This milestone marks an important advancement for sleep medicine in Japan and brings forward a treatment option that is not classified as a controlled substance. We continue to strengthen Viatris’ innovative medicines portfolio in this strategically important market by investing in differentiated therapies for patients.”

Excessive daytime sleepiness is a clinically significant symptom of both OSA and narcolepsy, representing an area of unmet medical need in Japan. In patients with OSA, excessive daytime sleepiness can adversely affect daily functioning, work productivity, and quality of life and may persist despite treatment of airway obstruction.

The approval was supported by positive data from domestic phase 3 clinical trials in Japan, along with multiple international clinical studies evaluating the drug in patients with narcolepsy and those with OSAS experiencing excessive daytime sleepiness despite CPAP therapy.

Discovered by Bioprojet, WAKIX has previously received approvals for narcolepsy in more than 38 countries, including the United States and across Europe, and for OSA-related excessive daytime sleepiness in more than 29 European countries.

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