www.fdanews.com/articles/197041-european-commission-approves-new-formulation-of-takedas-entyvio
European Commission Approves New Formulation of Takeda’s Entyvio
May 11, 2020
The European Comission has approved a subcutaneous formulation of Takeda Pharamceuticals’ Entyvio (vedolizumab) for treatment of ulcerative colitis and Crohn's disease.
The approval was based on the results of a phase 3 trial of the formulation as a maintenance therapy in adult patients. The participants achieved clinical response at week six following two doses of the intravenous formulation.
Takeda said the new formulation will be available in both a pre-filled syringe and a pre-filled pen.