Posted by Michael Wonder on 02 Mar 2020
Takeda receives positive CHMP opinion for subcutaneous formulation of vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease
28 February 2020 - If approved, the additional treatment modality will provide more options for how patients in Europe receive the gut-selective biologic vedolizumab.
Takeda today announced that the CHMP of the EMA has recommended the approval of a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Takeda proposes to make vedolizumab SC available in both a pre-filled syringe and a pre-filled pen.
The CHMP opinion will now be reviewed by the European Commission. If approved, vedolizumab will become the only maintenance therapy for UC or CD with both intravenous and subcutaneous formulations across the European Union, providing greater options for how patients receive their treatment.
