Takeda Announces Data From Phase 3 KEPLER Study Shows ENTYVIO May Provide Possibility Of Clinical Remission For Patients With Active Ulcerative Colitis;

Takeda (TSE:4502/NYSE:TAK) today announced positive data from the pivotal Phase 3 KEPLER trial, which demonstrated that ENTYVIO® (vedolizumab) can offer the possibility of clinical remission for patients ages 2 and older with moderately to severely active ulcerative colitis (UC), a chronic inflammatory disease of the gastrointestinal tract and one of the two most common types of inflammatory bowel disease.1,2 The results, presented at the 21st Congress of the European Crohn's and Colitis Organisation (ECCO), show vedolizumab's promising efficacy and safety profile in a patient population where therapy options remain limited. With KEPLER, Takeda is continuing to generate deeper scientific insights and identify additional patient populations who may benefit from vedolizumab, a cornerstone therapy for adults with ulcerative colitis. Vedolizumab is marketed under the trade name ENTYVIO

The KEPLER Phase 3 study included 120 children and adolescents 2 to 17 years-old with moderately to severely active UC who had an inadequate response to conventional treatments (such as steroids and immunomodulators) and/or tumor necrosis factor (TNF) antagonists. Study participants received open-label intravenous (IV) vedolizumab during a 14 week open-label induction period.1 Ninety-three (93) of 120 patients who achieved a clinical response at Week 14 were then randomized to low dose (n=47) or high dose (n=46) maintenance therapy with vedolizumab every 8 weeks.