Takeda Pharmaceutical Co. Ltd. announced positive results from the Phase 3 KEPLER trial evaluating intravenous ENTYVIO (vedolizumab) in children and adolescents aged 2–17 with moderately to severely active ulcerative colitis who had an inadequate response to conventional therapies and/or TNF antagonists. In patients who responded at Week 14 and entered the randomized maintenance phase, 47.3% achieved clinical remission at Week 54, and 34.7% achieved clinical remission at Week 14; the most frequently reported treatment-emergent adverse events (≥10%) included upper respiratory infection, ulcerative colitis worsening, and pyrexia. The results were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), and Takeda said it plans to submit marketing applications in the U.S., EU, and other markets for pediatric use in this indication.

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