Japan’s Takeda Pharmaceutical Co. Ltd. (TKPYY.PK) announced Thursday that new phase 3 data show investigational subcutaneous or SC formulation of Vedolizumab meets primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active ulcerative colitis.
The VISIBLE 1 clinical trial evaluates the efficacy and safety of SC formulation of vedolizumab for maintenance therapy in adult patients with moderately to severely active ulcerative colitis or 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 company noted that the safety data were consistent with the known safety profile of vedolizumab, and no new safety signals were identified.
The data will be discussed with global health authorities, including the U.S. Food and Drug Administration and European Medicines Agency.
Further data from the trial will be presented at a future scientific congress.
by RTTNews Staff Writer
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