Viatris Inc. announced the filing of Supplemental New Drug Applications (sNDAs) with Japan's Ministry of Health, Labor and Welfare (MHLW) for the approval of Effexor SR Capsules (venlafaxine hydrochloride). The applications seek approval to treat adults with Generalized Anxiety Disorder (GAD), an indication for which no other treatment option is currently approved in Japan.
The sNDA filing is supported by positive results from the Phase 3 placebo-controlled, randomized, double-blind, multicenter study (B2411367) of venlafaxine in Japanese patients with GAD. This study achieved its primary objective of demonstrating superiority in anxiolytic effects compared to placebo at 8 weeks, based on the Hamilton Anxiety Rating Scale (HAM-A) total score.
Results from a long-term extension study of venlafaxine in Japanese outpatients with GAD were also included as part of the applications. This comprehensive data package reinforces the potential of Effexor to address a significant unmet medical need in Japan, where GAD may be significantly underdiagnosed.
This filing represents a key milestone in Viatris's strategy to advance novel assets through its diversified pipeline. Successful approval would position Effexor as the first available treatment option for GAD in Japan, potentially opening a new market and contributing to the company's future revenue growth.
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