Viatris receives Japan WAKIX approval

• Viatris received approval in Japan for WAKIX (pitolisant) for excessive daytime sleepiness and narcolepsy.
• The approval covers patients with obstructive sleep apnea receiving airway obstruction treatment and narcolepsy types 1 and 2.
• WAKIX is the first approved histamine H3 receptor antagonist/inverse agonist in Japan for these uses.

Viatris (NASDAQ:VTRS) received approval from Japan’s Ministry of Health, Labour and Welfare for WAKIX (pitolisant) to treat excessive daytime sleepiness associated with obstructive sleep apnea syndrome and narcolepsy.

The approval allows WAKIX to be used in obstructive sleep apnea patients already receiving airway obstruction treatment and in patients with narcolepsy types 1 and 2, with or without cataplexy.

The approval was based on results from domestic Phase 3 clinical trials in Japan and international clinical studies evaluating WAKIX in narcolepsy and obstructive sleep apnea patients experiencing excessive daytime sleepiness despite continuous positive airway pressure therapy.

Viatris said the approval expands its innovative medicines portfolio in Japan, while WAKIX is not classified as a controlled substance in the country.

Viatris develops and commercializes medicines across multiple therapeutic areas, including branded and generic treatments in global markets.

WAKIX works as a histamine H3 receptor antagonist/inverse agonist and is designed to address excessive daytime sleepiness associated with sleep-related disorders.