Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis
Shots:
- Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists
- Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved remission at Wk. 14 and 29% attained sustained remission at both Wks. 14 and 54 (i.e. 2EP); vedolizumab’s safety profile was generally consistent with est. safety profile in adults, with no new safety signals
- Results were presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO); Takeda plans to submit marketing applications in the US, EU, and other markets for pediatric UC
Ref: Takeda | Image: Takeda |Press Release
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