Viatris has received approval from Japan’s Ministry of Health, Labour and Welfare for WAKIX (pitolisant) to treat excessive daytime sleepiness (EDS) linked to obstructive sleep apnea syndrome (OSAS) and narcolepsy.
The approval covers patients with OSAS who are receiving treatment to keep their airways open, as well as adults with narcolepsy types 1 and 2, both with and without cataplexy.
WAKIX is a histamine H3 receptor antagonist/inverse agonist. According to Viatris, it is the first medicine in this class approved in Japan for these indications.
Excessive daytime sleepiness is a common symptom of both obstructive sleep apnea and narcolepsy. In people with OSAS, sleepiness can continue even after treatment for airway obstruction and may affect daily activities, work and quality of life.
Narcolepsy is a chronic neurological condition that affects a person’s ability to stay awake. Type 1 narcolepsy is associated with cataplexy, which causes sudden muscle weakness, while type 2 narcolepsy does not involve cataplexy.
Philippe Martin, chief R&D officer at Viatris, said the approval provides a new treatment option for people with these sleep disorders in Japan. He also noted that WAKIX is not classified as a controlled substance.
The Japanese approval was supported by positive results from domestic Phase 3 clinical trials, along with data from international clinical studies involving patients with narcolepsy and patients with OSAS who continued to experience excessive daytime sleepiness despite treatment with continuous positive airway pressure (CPAP).
Viatris said the approval strengthens its portfolio of innovative medicines in Japan and adds a differentiated treatment option for patients with sleep-related disorders.
The decision comes as excessive daytime sleepiness remains an area of unmet medical need in Japan, particularly among people whose symptoms continue despite treatment for the underlying condition.