OSAKA, Japan–(BUSINESS WIRE)– Data to be discussed with global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Takeda Pharmaceutical Company Limited [TSE:4502] ("Takeda") today announced top-line results from the VISIBLE 1 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy. In the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC beginning at week 6 and every two weeks following achieved clinical remission** at week 52 compared to placebo. The safety data were consistent with the known safety profile of vedolizumab, and no new safety signals were identified.