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
Full Article: https://www.healio.com/gastroenterology/practice-management/news/online/3aae1140-b4cc-4243-b702-8b3e4314054d/cmhp-recommends-approval-of-entyvio-for-ulcerative-colitis-crohns-disease