Viatris Expands Portfolio with Approval of Effexor® for Generalised Anxiety Disorder in Japan
Tuesday, March 24, 2026
Viatris Inc. has received approval from Ministry of Health, Labour and Welfare for Effexor® SR 37.5 mg and 75 mg capsules (venlafaxine hydrochloride) to treat adults with generalised anxiety disorder (GAD). The decision introduces the first approved treatment specifically for adult GAD patients in Japan, addressing a long-standing gap in mental health care. The medicine is already available in the country for major depressive disorder and will now also support patients with GAD.
GAD is a common and disabling mental health condition that can significantly affect daily life. Studies suggest that around 7.6% of the population in Japan may experience symptoms consistent with the disorder.
The approval is based on results from a Phase III, placebo-controlled, randomised, double-blind, multi-centre study conducted in Japan. The trial showed that venlafaxine provided a significant improvement in anxiety symptoms compared with placebo after eight weeks, measured using the Hamilton Anxiety Rating Scale. All secondary study goals were also achieved.
Effexor® demonstrated a safety profile consistent with previous findings. Discontinuation rates due to treatment-related side effects were low, and no serious or severe adverse events linked to treatment were reported. Supporting data from a long-term extension study in Japanese outpatients were also included in the submission.
Effexor® is already approved for GAD treatment in more than 80 countries outside Japan, and this latest decision supports broader access to the therapy in the region.
Source: prnewswire.com
