Entyvio® (Vedolizumab) receives marketing authorisation for Ulcerative Colitis & Crohn’s Disease

May 13, 2020

European Commission Approves Subcutaneous Formulation of Entyvio® (Vedolizumab) for use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

Takeda has announced that the European Commission has granted a Marketing Authorisation for the subcutaneous (SC) formulation of Entyvio® (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen.

UC and CD are two of the most common forms of inflammatory bowel disease (IBD) and affect more than two million people in Europe. This decision by the European Commission means that EntyvioSC is now approved for use in the 27 member states of the European Union, plus the United Kingdom, Norway, Liechtenstein and Iceland.

“We are delighted that the European Commission has approved the subcutaneous formulation of Entyvio. This allows physicians and adult patients to choose the delivery method that works best for each individual patient,” said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda. “Takeda’s commitment to treating gastrointestinal disease means that we are always looking to innovate to provide further therapeutic options to better meet the needs of the patients we serve.”

The European Commission approval was based on the pivotal phase 3 VISIBLE trials which assessed the safety and efficacy of a SC formulation of Entyvio 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 an interim analysis of an ongoing, long-term, open-label extension study of patients from VISIBLE 1 and VISIBLE 2 were also considered.

Takeda strongly believes in the benefit that Entyvio SC can bring to adult patients who live with moderately to severely active UC and CD and remains committed to working with regulatory authorities to bring this important option to patients as quickly as possible. In addition to having received approval from the European Commission, Entyvio SC has been submitted for regulatory review with other regulatory authorities worldwide.