Healthcare company Viatris Inc (Nasdaq: VTRS) announced on Wednesday that it has received approval from Japan's Ministry of Health, Labour and Welfare for WAKIX (pitolisant) to treat excessive daytime sleepiness associated with obstructive sleep apnoea syndrome in patients receiving airway obstruction treatment, as well as narcolepsy types 1 and 2.

Viatris said WAKIX is the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications. The approval was supported by positive data from Japanese Phase 3 trials and international clinical studies in narcolepsy and obstructive sleep apnoea patients experiencing excessive daytime sleepiness despite continuous positive airway pressure therapy.

WAKIX is an oral treatment that modulates the brain's sleep-wake pathways. It is licensed exclusively to Viatris for Japan and has previously been approved for narcolepsy in more than 38 countries and for obstructive sleep apnoea-related excessive daytime sleepiness in more than 29 European countries.