Viatris Seeks Approval in Japan for EFFEXOR® to Treat Anxiety Disorder

Viatris Inc., a global healthcare company, has taken a significant step towards addressing an unmet medical need in Japan by filing applications with the Ministry of Health, Labor and Welfare for the approval of Effexor SR Capsules. This medication, known generically as venlafaxine hydrochloride, is a serotonin-noradrenaline reuptake inhibitor (SNRI) designed to treat adults suffering from generalized anxiety disorder (GAD). Currently, there are no approved treatment options specifically for GAD in Japan, making this development noteworthy.

The decision to file these applications follows successful Phase 3 clinical trials conducted by Viatris in Japan. These trials were placebo-controlled, randomized, double-blind, and multicenter, focusing on the effectiveness of venlafaxine in treating GAD. The study, known as Study B2411367, achieved its primary goal by demonstrating the superior anxiolytic effects of venlafaxine compared to a placebo over an 8-week period. This was measured through changes in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline, yielding a significant p-value of 0.012. Furthermore, all secondary efficacy endpoints outlined in the trial protocol were successfully met. Results from a long-term extension study involving Japanese outpatients with GAD were also included in the application.

Philippe Martin, Viatris' Chief R&D Officer, emphasized the importance of this milestone, highlighting that the filing of the supplemental New Drug Applications brings Japan closer to having its first approved treatment specifically for GAD in adults. The positive outcomes from the Phase 3 efficacy and safety studies provided a strong foundation for these applications. Effexor for GAD is part of Viatris' broader initiative to develop innovative solutions targeting significant unmet medical needs through their diversified pipeline.

Generalized anxiety disorder is characterized by persistent and excessive anxiety or worry about daily activities, often accompanied by symptoms such as sleep disturbances, muscle tension, restlessness, irritability, and difficulty concentrating. These symptoms can lead to impairments in social, occupational, or other functional areas. In Japan, the World Health Organization estimates that 2.6% of the population will experience GAD at some point in their lives. However, a recent study utilizing the GAD-7 screening tool found the prevalence of probable GAD in Japan to be 7.6%, suggesting that the condition may be underdiagnosed.

While outside of Japan, SSRIs and SNRIs are commonly recommended as first-line treatments for GAD, within Japan, Effexor is currently approved only for major depressive disorder in adults. The introduction of Effexor as a treatment option for GAD in Japan could provide much-needed relief for individuals suffering from this condition. Importantly, Effexor has already been approved for the treatment of GAD in over 80 countries worldwide.

Viatris Inc. is a healthcare company that bridges the gap between generic and brand-name medicines, aiming to enhance global healthcare access. The company supplies high-quality medications to approximately 1 billion patients annually, addressing health needs across various life stages and conditions. Headquartered in the United States, Viatris operates through global centers located in Pittsburgh, Shanghai, and Hyderabad, India, and is committed to tackling significant health challenges worldwide.