#Japan #Tokyo #Narcolepsy #Viatris #Wakix

Viatris' Innovative Treatment WAKIX® Approved in Japan

Viatris Inc. has recently made headlines with the announcement of the approval of WAKIX® (pitolisant) by Japan's Ministry of Health, Labour and Welfare. This new treatment is designed specifically for managing excessive daytime sleepiness (EDS), a challenge faced by individuals suffering from obstructive sleep apnea syndrome (OSAS) as well as those with narcolepsy.

A Major Milestone in Sleep Medicine

According to Philippe Martin, Viatris' Chief R&D Officer, the approval of WAKIX marks a pivotal moment for sleep medicine in Japan as it is the country's first histamine H3 receptor antagonist/inverse agonist approved specifically for these conditions. Martin emphasized that this therapeutic option is particularly significant because it is not categorized as a controlled substance, thus offering broader accessibility for patients in need.

Addressing Unmet Needs

Excessive daytime sleepiness is a prevalent symptom among patients with narcolepsy and OSAS, leading to detrimental effects on daily activities, work efficiency, and overall quality of life. For many, EDS persists despite existing treatments aimed at airway obstruction. Narcolepsy itself is characterized by recurrent episodes of excessive daytime sleepiness, further complicating the lives of those affected. The disorder comprises type 1 narcolepsy, which comes with cataplexy — sudden muscle weakness — and type 2, which does not.

Data from domestic Phase 3 clinical trials in Japan, in addition to various international studies, have bolstered the efficacy of WAKIX in managing both narcolepsy and OSAS-related EDS, particularly in individuals who continue to experience symptoms despite the use of continuous positive airway pressure (CPAP) therapy.

WAKIX: A Groundbreaking Approach

WAKIX is an orally administered medication that functions as a histamine H3 receptor antagonist/inverse agonist, which influences the brain's sleep-wake mechanisms. While licensed for the Japanese market exclusively, this innovative treatment has received prior approvals in over 38 countries around the globe for narcolepsy, including the United States and various European nations. Furthermore, it has been recognized for its effectiveness against OSAS-related excessive daytime sleepiness in more than 29 European countries. Significantly, it has been designated an orphan drug in Japan for the treatment of narcolepsy, further emphasizing its importance.

The Role of Viatris in Global Healthcare

Viatris, listed on Nasdaq as VTRS, is a vital player in the global healthcare landscape, striving to improve the health of individuals at every life stage. The company emphasizes swift, innovative responses to patient needs — whether through new drug development, ensuring robust supply chains, or entrepreneurial advancements. Their wide-ranging portfolio includes generics, value-added products, established brands, and groundbreaking therapies for unmet medical requirements. The company's headquarters are located in the U.S., with additional global centers established in Pittsburgh, Shanghai, and Hyderabad.

In summary, the approval of WAKIX represents more than just an advancement in sleep medicine — it signifies hope for countless individuals affected by narcolepsy and OSAS. This innovative therapy presents a unique, non-controlled option for patients and showcases Viatris' commitment to advancing healthcare solutions in Japan and beyond.