Patient reported outcomes, vedolizumab efficacy and safety data and comparative cost-effectiveness studies are among 20 abstract presentations
Osaka, Japan, October 19, 2015 – Takeda Pharmaceuticals Company Limited [TSE: 4502], (“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 2015 American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21, and during the United European Gastroenterology Week (UEGW) annual meeting, which takes place in Barcelona, Spain from October 24-28.
Eleven Takeda-sponsored posters, as well as one oral presentation entitled ‘Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan, Siegel, Melmed, et al.),will be featured during the ACG meeting. Data presented during the UEGW meeting will highlight findings from an analysis of the cost-effectiveness of vedolizumab as a treatment for UC compared with conventional therapy in the United Kingdom, as well as results from a multinational study investigating indicators of suboptimal therapy among UC and CD patients treated with tumor necrosis factor antagonists (TNF-α).
“At Takeda we strongly believe in the importance of supporting patients around the world with innovative treatment options, and this is why we remain committed to excellence in our scientific exploration of vedolizumab,” said Dr. Michael Smyth, Global Brand Medical Director, Gastroenterology, Takeda Pharmaceuticals. “The extensive study results being presented at these congresses demonstrate that vedolizumab is an important addition to the therapeutic options available for patients living with ulcerative colitis and Crohn’s disease.”
Vedolizumab was approved as a gut-selective humanized monoclonal antibody available in the European Union on May 27, 2014, under the trade name Entyvio® (vedolizumab). Entyvio is also available in the United States (U.S.) following U.S. Food and Drug Administration (FDA) approval on May 20, 2014. It is the first and only biologic therapy to be approved in the European Union, as well as 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 Takeda-sponsored abstracts presented at ACG is as follows:
On Sunday 18 October
On Monday 19 October
On Tuesday 20 October
The following presentations will be held during UEGW:
On Monday 26 October
On Tuesday 27 October
On Wednesday 28 October
About ulcerative colitis and Crohn’s disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are marked by inflammation in the GI tract. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body’s immune system, and environmental factors play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.
About Entyvio® (vedolizumab)
Vedolizumab, developed for the treatment of UC and CD, is a humanized monoclonal antibody that is designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, 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 UC and CD. By inhibiting alpha4beta7, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.
INDICATIONS: ENTYVIO™ (vedolizumab)
Adult Ulcerative Colitis (UC)
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 (it says “conventional” therapy in the SmPC):
Adult Crohn's Disease (CD)
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 (it says “conventional” therapy in the SmPC):
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
The risk of malignancy is increased in patients with Ulcerative colitis and Crohn’s disease. (from SmPC)
USPI/SmPC version - includes “Very Common” and “Common” AEs from SmPC: Most common adverse reactions include: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, Gastroenteritis, Pharyngitis, nasal congestion, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, paraesthesia, hypertension, anal abscess, anal fissure, dyspepsia, constipation, abdominal distension, flatulence, haemorrhoids, eczema, erythema, night sweats, acne, muscle spasms, muscular weakness, oropharyngeal pain, and pain in extremities.
Please consult with your local regulatory agency for approved labeling in your country.
For U.S. Audiences, please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.
About Takeda Pharmaceuticals 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.
TEL: (224) 554-1474
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