EU approves Entyvio subcutaneous formulation for active ulcerative colitis or Crohn’s disease.- Takeda

Takeda Pharmaceutical announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen. The European Commission approval was based on the pivotal phase III VISIBLE trials which assessed the safety and efficacy of a SC formulation of Entyvio as maintenance therapy in adult patients with moderately to severely active UC or CD who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2. Data from an interim analysis of an ongoing, long-term, open-label extension study of patients from VISIBLE 1 and VISIBLE 2 were also considered.