Vedolizumab Maintenance Therapy in Active Ulcerative Colitis or Crohn’s Disease Receives Positive CHMP Opinion

Takeda Pharmaceutical Company Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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.

“Today’s positive CHMP opinion marks a key step forward in our goal to provide greater options to patients with ulcerative colitis and Crohn’s disease,” said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda in a press release. “Ulcerative colitis and Crohn’s disease are life-long diseases and it is important that patients have treatment options that suit their different preferences and lifestyles. We look forward to the European Commission’s decision and the opportunity to bring a subcutaneous formulation of vedolizumab to these patients across Europe.”

Read the full press release here.