CMHP recommends approval of Entyvio for ulcerative colitis, Crohn’s disease
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of the subcutaneous formulation of Entyvio for maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease, according to a press release.
The approval was based on data from pivotal phase 3 VISIBLE trials. The next step is a review by the European Commission.
Takeda, the manufacturer of Entyvio (vedolizumamb), intends to make the drug available in a pre-filled syringe and pre-filled pen.
“Today’s positive CMHP opinion marks a key step forward in our goal to provide greater options to patients with ulcerative colitis and Crohn’s disease,” Adam Zaeske, head of Gastroenterology Franchise, Europe and Canada Business Unit, Takeda, said in the 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.”