Posted by Michael Wonder on 02 Apr 2019
European Medicines Agency accepts Takeda’s marketing authorisation application for a subcutaneous formulation of vedolizumab for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease
1 April 2019 - Additional treatment modality would provide greater choice in how patients receive gut-selective biologic vedolizumab.
Takeda today announced that the EMA has accepted a marketing authorisation line extension application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for 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 pre-filled syringe and pen options.
The application is based on the pivotal VISIBLE 1 phase 3 study, which assessed the safety and efficacy of a SC formulation of vedolizumab as maintenance therapy in 216 adult patients with moderately to severely active UC who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy at weeks 0 and 2.1 Interim data from other ongoing VISIBLE studies involving patients with CD were also included in the application. The results of VISIBLE 1 were presented at the 2018 United European Gastroenterology (UEG) Week Congress in Vienna, Austria.
