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Viatris Files Supplemental New Drug Applications to Japan's Ministry of Health, Labor and Welfare for the Approval of EFFEXOR® for the Treatment of Generalized Anxiety Disorder
Aiming to address a significant unmet need for which no other approved treatment option is available for generalized anxiety disorder patients in Japan
About this update from Viatris Inc.
[{"type":"text","content":"Aiming to address a significant unmet need for which no other approved treatment option is available for generalized anxiety disorder patients in Japan\nPITTSBURGH, April 21, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today 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.\nAs 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.1 \n\"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.\"\nPatients 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.2 In Japan, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime.3 A recent study using a screening tool (GAD-7 ≧ 10) reported the prevalence of probable GAD in Japan is 7.6%.4 This data ...