Viatris Secures Effexor SR 37.5/75mg Approval as Japan’s First GAD Therapy
Japan's Ministry of Health has approved Effexor SR 37.5 mg and 75 mg capsules for adult generalized anxiety disorder, making it the first approved GAD treatment in the country. The decision follows a Phase 3 trial showing an anxiolytic effect (p=0.012) at eight weeks and meets all seven secondary endpoints.
1. Approval Details
Japan’s Ministry of Health, Labour and Welfare approved Effexor SR 37.5 mg and 75 mg capsules for adults with generalized anxiety disorder, marking the first GAD treatment authorized in the country and expanding Viatris’ established brand portfolio in Japan.
2. Clinical Trial Results
The approval follows a Phase 3 randomized, placebo-controlled multicenter study in Japanese patients, which achieved superiority on the Hamilton Anxiety Rating Scale at eight weeks (p=0.012) and met all seven secondary efficacy endpoints, with low discontinuation rates and no serious adverse events reported.
3. Market Impact and Strategy
Generalized anxiety disorder affects an estimated 7.6% of Japan’s population, and prior to this approval no treatments were sanctioned for adult GAD; this milestone supports Viatris’ lifecycle strategy and could drive growth in its CNS franchise as Effexor is already indicated for depression and GAD in over 80 other countries.