Data to feature additional insights into vedolizumab and elements of inflammatory bowel disease (IBD)
Takeda Pharmaceuticals, U.S.A., Inc. (“Takeda”), today announced that data highlighting the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD), will be presented during the Crohn’s & Colitis Foundation of America’s 2016 Advances in Inflammatory Bowel Diseases (AIBD) annual conference, held in Orlando, Florida on December 8-10.
Seventeen Takeda-sponsored posters will be presented during the AIBD meeting, focused on a variety of topics important to the IBD community, including real-world data about vedolizumab treatment.
“As we continue our ongoing investigation and characterization of vedolizumab in clinical practice, we are able to provide additional insights that add to the growing body of scientific evidence supporting the full potential of this important compound,” said Karen Lasch, U.S. medical director, Gastroenterology, Takeda Pharmaceuticals. “We are pleased to have this opportunity to further engage with the professional community at AIBD and share additional data, as we work toward our common goal of improving the lives of patients living with ulcerative colitis and Crohn’s disease.”
Vedolizumab is approved as a humanized monoclonal antibody and is available in the United States (U.S.) under the trade name Entyvio® (vedolizumab). It is the first and only biologic therapy to be approved in the U.S., simultaneously for the treatment of adults with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha antagonist.
A full list of the 17 Takeda-sponsored abstracts accepted for presentation at the 2016 AIBD Annual Conference is as follows:
About Entyvio® (vedolizumab)
Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Entyvio does not bind to or inhibit function of the alpha4beta1 and alpha E beta 7 integrins and does not antagonize the interaction of alpha4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The alpha4beta7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.
INDICATIONS: ENTYVIO (vedolizumab)
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.
IMPORTANT SAFETY INFORMATION
About Ulcerative Colitis and Crohn’s Disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are marked by inflammation in the lining of the gastrointestinal tract. UC impacts the large intestine only, which includes the colon and the rectum, while CD can impact any part of the digestive tract, and predominantly affects the ileum. There is no known cause for UC and CD, although many researchers believe that the interaction between genes, the body’s immune system, and environmental factors may play a role.
Takeda’s Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. Beginning in the 1990’s Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors. Since that time, Takeda’s global capabilities have expanded into the specialty care market in gastroenterology and biologics with a focus on ulcerative colitis and Crohn’s disease. Takeda's expertise also remains focused on therapeutic agents that work to reduce the production of acid in the stomach, and options for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and opioid-induced constipation. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.
About Takeda Pharmaceuticals U.S.A., Inc.
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.
The company has a commercial presence covering around 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of R&D focus include central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.
Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.
Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
Takeda Pharmaceuticals U.S.A., Inc.