U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease - Seite 2

“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

*Please refer to “U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis”, dated September 27, 2023.

**Clinical response is defined as a ≥70-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline (Week 0).¹

***Clinical remission is defined as CDAI score of ≤150 at Week 52.¹

Takeda does not expect a material impact on the consolidated financial statements as a result of this approval.

About ENTYVIO (vedolizumab)

Vedolizumab is a biologic therapy and is approved for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market).^1,2 Vedolizumab SC has been granted marketing authorization in the United States, European Union and more than 50 countries. Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union. Globally, vedolizumab IV and SC have more than one million patient years of exposure to date.³ Vedolizumab 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).⁴ MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.⁵ The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.⁴ These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn’s disease.^4,6,7 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.⁴