TOKYO (dpa-AFX) - Takeda Pharmaceutical Company Limited (TAK) announced that CHMP, the Committee of the European Medicines Agency, has recommended the approval of a subcutaneous formulation of the gut-selective biologic vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn's disease. The positive opinion was based on the pivotal phase 3 VISIBLE trials.
Takeda Pharma noted that, if approved, vedolizumab will become the only maintenance therapy for ulcerative colitis or Crohn's disease with both intravenous and subcutaneous formulations across the European Union.
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