Japan Approves First-Ever Treatment for Generalised Anxiety Disorder in Adults

Viatris Inc. has secured approval in Japan for Effexor SR, a treatment for adults with Generalised Anxiety Disorder (GAD). The decision marks the first and only authorised therapy for this condition in the country. The company, headquartered in the U.S., operates globally with key centres in Pittsburgh, Shanghai, and Hyderabad.

GAD is a mental health condition defined by persistent, excessive worry about daily life. It affects around 7.6% of Japan's general population and often disrupts work, relationships, and routine activities. Until now, no dedicated treatment had been approved for adults with the disorder in the country.

A Phase 3 study demonstrated that Effexor SR significantly reduced anxiety symptoms compared to a placebo after eight weeks. The trial also confirmed the drug's safety profile, aligning with its established record in non-Japanese patients. Regulators reviewed these findings before granting approval.

Viatris, a global healthcare firm, focuses on expanding access to treatments across different life stages. In Japan, its portfolio already includes Spydia Nasal Spray, with additional investigational products like pitolisant and selatogrel in development. The approval of Effexor SR addresses a long-standing gap in mental health care for GAD patients nationwide.

The approval provides a new option for adults struggling with GAD in Japan. Effexor SR's effectiveness and tolerability were key factors in the regulatory decision. Patients and clinicians now have access to a dedicated therapy for managing chronic anxiety symptoms.