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Takeda Pharmaceuticals Announces FDA Acceptance of Biologics Licence Application for ENTYVIO®

Thursday, September 14, 2023

Takeda Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics Licence Application (BLA) for the subcutaneous (SC) administration of ENTYVIO® (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohn's disease (CD) after undergoing induction therapy with ENTYVIO intravenous (IV).

Vedolizumab is a biologic therapy available in both intravenous (IV) and subcutaneous (SC) formulations. Vedolizumab is a humanised monoclonal antibody designed to specifically block the alpha4beta7 integrin. 

The BLA application for the subcutaneous administration of ENTYVIO for the treatment of adults with moderately to severely active CD is based on data from a Phase 3 clinical trial called VISIBLE 2. 

This trial evaluated the safety and effectiveness of an SC formulation of ENTYVIO as maintenance therapy in comparison to a placebo in 409 adult patients with moderately to severely active CD who had achieved a clinical response* at week 6 after receiving two doses of open-label vedolizumab IV therapy at weeks 0 and 2.

This action inhibits the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), which plays a role in inflammatory processes within the intestines. Notably, it does not affect vascular cell adhesion molecule 1 (VCAM-1).

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