Japan’s Ministry of Health, Labour and Welfare approved Viatris’ Wakix (pitolisant) for excessive daytime sleepiness. The treatment is indicated for patients suffering from obstructive sleep apnea and narcolepsy.
This marks the first Japanese approval of a histamine H3 receptor antagonist for these conditions. Regulators did not classify the drug as a controlled substance, providing a new option for significant unmet medical needs in the country.
The approval follows positive Phase 3 clinical trial data from both Japanese and international studies. French company Bioprojet discovered the drug and licensed it to Viatris exclusively for the Japanese market.