9 May 2019 - An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a gut-selective mode of action.
Takeda Pharmaceutical Company today announced that the U.S. FDA has accepted for review a biologics license application for a subcutaneous formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis. Takeda proposes to make vedolizumab subcutaneous 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 subcutaneous formulation of vedolizumab as maintenance therapy in 216 adult patients with moderately to severely active ulcerative colitis who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2.