Viatris recently announced that Japan's Ministry of Health, Labour and Welfare (MHLW) 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, and approval for narcolepsy (type 1 and 2–with and without cataplexy). WAKIX is the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications.

Philippe Martin, Chief R&D Officer, Viatris, said, "As Japan's first approved histamine H3 receptor antagonist/inverse agonist for these conditions, WAKIX offers a much-needed novel treatment option for patients. 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."

EDS is a shared and clinically significant symptom of both OSAS and narcolepsy and remains an area of unmet medical need in Japan. In patients with OSAS, EDS can adversely affect daily functioning, work productivity, and quality of life and may persist despite treatment of airway obstruction. Narcolepsy is a chronic neurological disorder characterised by EDS and an impaired ability to maintain wakefulness. The condition can also have a significant impact on patients' daily lives and is often associated with delays in diagnosis.

Narcolepsy includes both type 1, which is associated with cataplexy (sudden muscle weakness), and type 2, which is not associated with cataplexy.

The approval of Viatris' WAKIX was supported by positive data from domestic phase 3 clinical trials in Japan as well as multiple international clinical studies evaluating WAKIX in patients with narcolepsy and patients with OSAS experiencing EDS despite treatment with Continuous Positive Airway Pressure (CPAP) therapy.