Phase III VISIBLE 1 trial of subcutaneous Entyvio meets endpoint in ulcerative colitis.- Takeda.
Takeda has announced that the Phase III VISIBLE 1 trial of investigational subcutaneous formulation Entyvio (vedolizumab) for patients with ulcerative colitis has met its primary endpoint. The trial was testing Entyvio as a maintenance therapy for adult patients with moderately to severely active ulcerative colitis (UC) who are responding well to Entyvio.
The results showed that significantly more patients receiving the SC formulation of vedolizumab achieved clinical remission at week 52 versus placebo. In addition, the safety data were consistent with the known safety profile of Entyvio, which is already marketed in an intravenous form, and no new safety signals were identified.
Takeda has announced yesterday that it had submitted Entyvio for approval against Crohn’s disease in Japan.
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