Takeda takes step towards EU Entyvio extension

The European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for subcutaneous (SC) Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

This additional treatment modality, on top of the existing intravenous (IV) formulation, would provide greater choice in how patients receive Takeda’s (TYO: 4502) gut-selective biologic.

Adam Zaeske, head of the gastrointestinal franchise for Takeda’s Europe and Canada Business Unit, said: “This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe.