Viatris Submits Marketing Application for Effexor SR in Japan for Generalized Anxiety Disorder

Viatris Submits Marketing Application for Effexor SR in Japan for Generalized Anxiety Disorder

Viatris Inc. (NASDAQ: VTRS) announced the submission of a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Effexor SR (venlafaxine hydrochloride extended-release), a serotonin-norepinephrine reuptake inhibitor (SNRI). This application seeks approval for the treatment of generalized anxiety disorder (GAD) in adults, an indication for which no therapies are currently approved in Japan.

Global Context and Effexor’s Position
Globally, selective serotonin reuptake inhibitors (SSRIs) and SNRIs are recommended as first-line treatments for GAD. Effexor is already approved in Japan for major depressive disorder (MDD) in adults. Outside Japan, Effexor holds GAD approvals in over 80 countries, underscoring its established role in mental health treatment.

Market and Patient Impact
The submission highlights Viatris’s commitment to addressing unmet medical needs in Japan. If approved, Effexor SR would offer a new treatment option for adults with GAD, aligning with global standards of care and potentially improving patient outcomes in a market lacking approved therapies for this condition.-Fineline Info & Tech