Takeda's vedolizumab meets Crohn's endpoint
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said vedolizumab met two of three co-primary endpoints in the Phase III GEMINI II trial to treat moderate to severe Crohn's disease (CD). The humanized mAb against integrin alpha(4)beta(7) led to a significantly greater proportion of patients in clinical remission at week six (induction phase) and at week 52 (maintenance phase) vs. placebo. However, vedolizumab missed the co-primary endpoint of improving enhanced response rate in the induction phase vs. placebo. Takeda said enhanced response rate is a clinical measure that includes observable changes in disease and patient reported outcomes. The trial enrolled 1,115 patients with moderately to severely active CD who have failed one or more conventional therapy, including tumor necrosis factor (TNF) alpha antagonists. ...