Viatris secures historic MHLW approval for Effexor SR as Japan’s first GAD treatment

Viatris (NASDAQ:VTRS) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Effexor® SR (venlafaxine hydrochloride) sustained-release capsules for the treatment of adults with generalized anxiety disorder (GAD).

With this decision, Effexor SR becomes the first and only medication specifically approved to treat GAD in Japan, a major regulatory breakthrough for the country's mental health landscape.

The approval is backed by a robust clinical data package, including a randomized, double-blind, placebo-controlled Phase 3 trial.

In the study, Effexor SR demonstrated a statistically significant improvement in the Hamilton Anxiety Rating Scale (HAM-A) total score compared to placebo (p=0.012).

Furthermore, long-term extension data supported the sustained efficacy and safety profile of the 37.5 mg and 75 mg doses in the Japanese patient population.

Generalized anxiety disorder is a chronic condition characterized by excessive, uncontrollable worry that interferes with daily functioning.

Despite its prevalence, Japanese clinicians have historically relied on off-label treatments or therapies approved for other mood disorders.

The inclusion of GAD as an indicated use for Effexor SR—which is already approved in Japan for depression and social anxiety disorder—provides a tailored, evidence-based option for psychiatrists and primary care physicians.

This approval aligns with Viatris’ broader strategy to maximize the value of its established brands portfolio while expanding its footprint in key international markets.