FDAnews
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.

View today's stories