Takeda Reports Phase 3 Efficacy Of Vedolizumab In Ulcerative Colitis, Crohn's Disease
By Cyndi Root
Takeda Pharmaceuticals will present data at a conference in Austria on its Phase 3 study of Entyvio (vedolizumab), which showed long-term efficacy in patients with ulcerative colitis (UC) and Crohn's disease (CD). The company announced the new data in a press release, saying that two of its abstracts to be presented at the United European Gastroenterology Week (UEGW) in Vienna, Austria demonstrate that 79 percent of the participants in a 52-week trial of the antibody treatment were in clinical remission in an 52-week extension study. Dr. Severine Vermeire of the University Hospitals Leuven in Belgium, said, "Current findings from the long-term extension study add to the evidence bank of vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn's disease."
About Entyvio
Entyvio (vedolizumab) is a monoclonal antibody that inhibits alpha4beta7 binding to fibronectin and intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), which is expressed in the gastrointestinal tract. By inhibiting alpha4beta7, vedolizumab limits white blood cells that infiltrate gut tissues and play a role in the inflammatory process. The Food and Drug Administration (FDA) approved vedolizumab in May 2014 and the agent is also approved in the EU and Australia.
New Entyvio Data
New data on Entyvio comes from the GEMINI LTS (Long-Term Safety) extension study of UC and CD patients. Patients from the 52-week GEMINI 1 and 2 studies were eligible to enroll in the LTS study, in which they received vedolizumab 300 mg intravenously every four weeks. Takeda is presenting two abstracts showing that 79 percent of those patients were in clinical remission at week 104. A third presentation shows that patients who discontinued the treatment due to a lack of efficacy showed disease improvement when the dosage frequency was increased without an increase in adverse events. A fourth abstract evaluates the infection rate in patients treated with vedolizumab and steroids and/or immunosuppressants (IMs).
About Takeda Pharmaceuticals International GmbH
Takeda Pharmaceuticals is headquartered in Zurich, Switzerland and is active in over 70 countries The company focuses on gastroenterology, oncology, the central nervous system, the cardiovascular system, and metabolic disorders. Vedolizumab was acquired through Takeda’s integration of Millenium Pharmaceuticals.