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

Viatris Files for EFFEXOR® Approval in Japan

Viatris Inc., a global healthcare provider listed on Nasdaq under the ticker VTRS, has recently submitted supplemental new drug applications to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval for EFFEXOR® (venlafaxine hydrochloride) in the treatment of generalized anxiety disorder (GAD). This move aims to fill a significant gap in treatment options available to patients suffering from this debilitating condition, as no other treatments have been officially sanctioned for GAD in Japan.

The company’s clinical data supporting this application comes from a comprehensive Phase 3 study carried out specifically in Japan. This randomized, double-blind, placebo-controlled study, designated as Study B2411367, demonstrated the efficacy of venlafaxine in alleviating anxiety symptoms over eight weeks. The results showed a statistically significant improvement in patients' anxiety levels as measured by the Hamilton Anxiety Rating Scale (HAM-A), with all defined secondary endpoints also meeting their efficacy benchmarks.

Philippe Martin, Chief R&D Officer at Viatris, remarked on this significant step: "The filing of our supplemental New Drug Applications marks a critical milestone in providing the first treatment option for generalized anxiety disorder to adults in Japan. Our positive findings from the Phase 3 studies have laid the groundwork for this application."

GAD impacts many individuals, leading to chronic anxiety about everyday situations, in addition to other challenging symptoms such as sleep disturbances, muscle tension, irritability, and cognitive difficulties. Japan's long-standing underdiagnosis of GAD affects approximately 2.6% of the population at some point in their lives, according to estimates from the World Health Organization. Recent studies suggest an even higher prevalence of around 7.6% among the population, highlighting the urgent need for effective treatment options.

The standard of care for GAD in many countries has favored the use of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). While EFFEXOR® is approved in over 80 countries globally for GAD, its approval in Japan has been awaited for some time as it is currently designated for major depressive disorder.

Viatris is poised to address this pressing healthcare need, demonstrating its commitment to aiding mental health management through its diversified pipeline. With access to EFFEXOR®, patients in Japan may benefit from a well-researched pharmacological option designed to alleviate the impacts of GAD, potentially improving their overall quality of life.

The submission of these applications also underscores Viatris' ongoing efforts to expand its reach and enhance treatment accessibility for various medical conditions across its operational territories. As GAD remains a growing public health concern worldwide, therapeutic advancements like EFFEXOR® promise to make significant contributions toward better mental health outcomes.

With the MHLW's evaluation process now underway, the success of Viatris' application will hinge on regulatory decisions that will inform the future landscape of mental health treatment in Japan. Whether this acquires approval will be pivotal for many individuals grappling with the challenges of GAD, representing hope for enhanced mental health resources in the region.

By advocating for important pharmacological advancements, Viatris aims to fulfill unmet needs and elevate the standards of mental health care globally.

For more detailed information about Viatris and its products, visit viatris.com.