Viatris Seeks MHLW Nod for Effexor SR to Treat Anxiety Disorder

Viatris Inc., a global healthcare company, announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan.

As previously announced, our phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan (Study B2411367) 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 (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met. These results and results from a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications.

""The filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalized anxiety disorder to adults in Japan,"" said Viatris chief R&D officer Philippe Martin. ""Positive results from our previously announced phase 3 efficacy and safety studies laid the foundation for our applications with the MHLW. Effexor for GAD is among a number of novel assets we are advancing through our diversified pipeline to address significant unmet needs.""

Patients with GAD can experience persistent, excessive and uncontrollable anxiety or worry about everyday life activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may impair patients' social, occupational, or other areas of functioning.  In Japan, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime.  A recent study using a screening tool (GAD-7 ? 10) reported the prevalence of probable GAD in Japan is 7.6%.  This data suggests that GAD may be significantly underdiagnosed in Japan.

Outside of Japan, selective serotonin reuptake inhibitors (SSRIs) and SNRIs are recommended as first-line drug therapies for patients diagnosed with GAD. EFFEXOR is currently approved in Japan for the indication of major depressive disorder in adults. EFFEXOR has also been approved for the indication of GAD in more than 80 countries outside of Japan.

Generalized Anxiety Disorder (GAD) is a mental health disorder whose central symptom is chronic and uncontrollable ""anxiety"" or ""worry"" about everyday life events or activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may cause impairment in social, occupational, or other areas of functioning. In Japan, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime. A recent study using a screening tool (GAD-7 ? 10) reported the prevalence of probable GAD in Japan is 7.6%.

Viatris Inc. is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.

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