Business
Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD)
Addresses a Significant Unmet Need in Japan as First and Only Approved Treatment Option for GADPITTSBURGH, March 23, 2026 /PRNewswire/ -- Viatris Inc.
About this update from Viatris Inc.
[{"type":"text","content":"Addresses a Significant Unmet Need in Japan as First and Only Approved Treatment Option for GADPITTSBURGH, March 23, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the treatment of adults with generalized anxiety disorder (GAD). Following the MHLW's decision, Effexor® becomes the first and only approved treatment option in Japan for adults living with GAD, addressing a long-standing unmet medical need in mental health and enabling new access to care. Effexor® is currently approved in Japan for the indication of major depressive disorder in adults, and with this approval, is now available to patients with GAD.GAD is among the most prevalent and highly disabling mental health conditions, negatively impacting patients' quality of life and disrupting activities of daily living. A recent study reported the prevalence of probable GAD in Japan as 7.6% of the general population.1\"The approval of Effexor® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need,\" said Philippe Martin, Viatris Chief R&D Officer. \"This approval also reflects our ability to effectively implement an optimized lifecycle strategy for our established brands and to leverage our deep local expertise.\"\"This approval marks the introduction of a new treatment option for adults in Japan living with GAD,\" said Corinne Le Goff, Viatris Chief Commercial Officer. \"We look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients.\"The approval of Effexor® for GAD is based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan (Study B2411367), which achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline ...