Takeda says it has late-stage trial results showing the benefit of an investigational subcutaneous formulation of Entyvio to patients with ulcerative colitis.
The Phase III VISIBLE 1 trial met its primary endpoint, the drugmaker said, showing that significantly more patients receiving the SC formulation of vedolizumab achieved clinical remission at week 52 versus placebo.
Also, 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.
“Meeting the primary endpoint of the VISIBLE 1 trial marks an exciting milestone in our approach to developing new ways to meet the needs of the ulcerative colitis patient community,” said Asit Parikh, head of Takeda’s Gastroenterology Therapeutic Area Unit.
“These results are encouraging and build on vedolizumab’s robust clinical profile with more than 200,000 patient years of exposure. We plan to discuss these data with health authorities with the aim of bringing this innovative treatment option to patients.”