Japan’s Ministry of Health, Labour and Welfare recently granted approval for a drug developed by Viatris, a global healthcare company with global centers in Pittsburgh, China and India.
The drug, WAKIX, is for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome (OSAS) in patients receiving treatment for airway obstruction and for type one and two narcolepsy with and without cataplexy. More than 38 countries, including the United States, previously granted approval for narcolepsy, and more than 29 European countries have granted approval for OSAS-related excessive daytime sleepiness.
“As Japan’s first approved histamine H3 receptor antagonist/inverse agonist for these conditions, WAKIX offers a much-needed novel treatment option for patients,” Philippe Martin, Viatris chief research and development officer, said. “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 symptom shared by OSAS and narcolepsy and is an unmet medical need in Japan. The ministry’s approval follows successful phase three clinical trials in Japan and multiple international clinical studies evaluating WAKIX.