Viatris Inc. (VTRS) announced that Japan’s Ministry of Health, Labour and Welfare has approved Effexor® SR 37.5 mg/75 mg capsules for the treatment of adults with generalized anxiety disorder (GAD). The approval makes Effexor the first and only GAD therapy approved in Japan, filling a long‑standing unmet medical need in the country’s mental‑health market.
Effexor® SR is a venlafaxine hydrochloride formulation that has been approved for GAD in more than 80 countries worldwide. In Japan, the drug’s approval follows a Phase 3, placebo‑controlled, double‑blind, multicenter study that demonstrated significant anxiolytic benefit at 8 weeks, with all seven secondary endpoints met and a safety profile consistent with the drug’s known profile. Japan’s GAD prevalence is estimated at 7.6 % of the population, meaning the approval opens access for a sizable patient base that previously had no approved pharmacologic options.
Viatris’s Chief R&D Officer Philippe Martin said, "The approval of Effexor® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value‑added therapies that address a significant unmet need." Chief Commercial Officer Corinne Le Goff added, "This approval marks the introduction of a new treatment option for adults in Japan living with GAD. We look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients." The approval expands the company’s existing venlafaxine brand, which is already approved in Japan for major depressive disorder, into a new therapeutic indication.
Viatris reported strong Q4 2025 results, with adjusted earnings per share of $0.57 and revenue of $3.7 billion, exceeding analyst expectations. The full‑year 2025 revenue was $14.3 billion, with adjusted EPS of $2.35, reflecting a modest year‑over‑year decline but solid performance in key growth regions. The company is also implementing a restructuring initiative expected to generate significant cost savings, positioning it to invest in new product launches such as Effexor® SR in Japan.
The approval is a strategic milestone that enhances Viatris’s innovative portfolio in a key international market. By leveraging its established distribution network and CNS expertise in Japan, the company is poised to capture a share of the GAD market while reinforcing its broader growth strategy across generics and complex‑generic businesses.
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