Takeda Receives Positive CHMP Opinion for Subcutaneous Formulation of Vedolizumab in Ulcerative Colitis or Crohn’s Disease

Mar 6, 2020

Takeda Receives Positive CHMP Opinion for Subcutaneous Formulation of Vedolizumab for use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

Takeda Pharmaceutical Company Limited (“Takeda”) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for use as 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 a pre-filled syringe and a pre-filled pen.

The CHMP opinion will now be reviewed by the European Commission. If approved, vedolizumab will become the only maintenance therapy for UC or CD with both intravenous and subcutaneous formulations across the European Union, providing greater options for how patients receive their treatment.

“Today’s positive CHMP opinion marks a key step forward in our goal to provide greater options to patients with ulcerative colitis and Crohn’s disease,” said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda. “Ulcerative colitis and Crohn’s disease are life-long diseases and it is important that patients have treatment options that suit their different preferences and lifestyles. We look forward to the European Commission’s decision and the opportunity to bring a subcutaneous formulation of vedolizumab to these patients across Europe.”

The positive opinion from the CHMP was based on the pivotal phase 3 VISIBLE trials which assessed the safety and efficacy of a SC formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active UC or CD who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2. Data from a long-term, open-label extension study of patients from VISIBLE 1 and VISIBLE 2 was also considered.

About the VISIBLE Clinical Trial Program

The VISIBLE clinical trial program aims to assess the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

The VISIBLE program consists of three phase 3 studies involving over 1,000 UC and CD patients which includes two randomized, double-blind, placebo-controlled studies examining the proportion of patients achieving clinical remission at week 52, and an open-label extension study to determine the long-term safety and efficacy of vedolizumab SC.2

About Entyvio® (vedolizumab)

Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation. It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD). By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.16

Vedolizumab IV is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist. Vedolizumab IV has been granted marketing authorization in over 60 countries, including the United States and European Union, with more than 415,000 patient years of exposure to date.