Takeda Receives European Commission Marketing Authorisation for Entyvio(R) (vedolizumab) for the Treatment of Ulcerative Colitis and Crohn's Disease

Zurich And Osaka, Japan (ots/PRNewswire) -

Takeda Pharmaceutical Company Limited and its wholly-owned
subsidiary, Takeda Pharmaceuticals International GmbH, today
announced that the European Commission (EC) has granted Marketing
Authorisation for Entyvio(R) (vedolizumab), a gut-selective humanized
monoclonal antibody, and the first and only biologic therapy to be
approved simultaneously for the treatment of adults with moderately
to severely active ulcerative colitis (UC) and adults with moderately
to severely active Crohn's disease (CD) who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a tumor necrosis factor-alpha (TNFalpha)
antagonist. UC and CD are the two most common types of inflammatory
bowel disease (IBD), affecting more than four million people
worldwide, including approximately 2.2 million in Europe."Ulcerative
colitis and Crohn's disease are serious conditions which can have a
devastating impact on patients, many of whom are in early adulthood
when they receive a diagnosis. As physicians, our aim is to help
patients achieve and maintain remission and disease control. The
approval of vedolizumab in Europe is an important step forward in the
treatment of ulcerative colitis and Crohn's disease. It is the first
gut-selective, biologic agent for this condition to be approved in
Europe and provides us with a new therapeutic option to help us to
tackle these challenging diseases," said Paul Rutgeerts, M.D., Ph.D.,
F.R.C.P, Emeritus Professor of Medicine, Catholic University of
Leuven, Belgium.

Vedolizumab is now approved for marketing in the 28 member states
of the European Union as well as Norway, Iceland and Liechtenstein.

"In clinical trials, vedolizumab demonstrated statistically
significant efficacy on a range of endpoints and was well-tolerated
in trials for both UC and CD and we are pleased that the European
Commission recognizes its clinical benefit," said Trevor Smith, Head
of Commercial Operations, Europe and Canada, Takeda. "Takeda has a
long history of research into gastrointestinal diseases, and we are
very excited to be moving into inflammatory bowel disease. We are
committed to expanding the range of therapeutic options available for
this patient community."

The Marketing Authorisation Application submission is supported by
the GEMINI(TM) Studies, a clinical program investigating vedolizumab
in 2,700 patients across nearly 40 countries. It is the largest Phase
3 clinical trial program conducted to date evaluating both UC and CD
patient populations in parallel. Enrolled patients had failed at
least one conventional therapy, including corticosteroids,
immunomodulators and/or a tumor necrosis factor-alpha (TNFalpha)
antagonist. TNFalpha antagonist and conventional therapy failure
patients included those with inadequate response (primary
non-responders), loss of response (secondary non-responders) or those
who were intolerant.

Vedolizumab is also now approved for marketing in the United
States, for the treatment of adult patients with moderately to
severely active UC or CD.

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 may 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(R)(vedolizumab)

Vedolizumab, developed for the treatment of UC and CD, is a
humanized monoclonal antibody that is designed to specifically
antagonize the alpha4beta7 (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.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, 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. Additional
information about Takeda is available through its corporate website,
http://www.takeda.com.

ots Originaltext: Takeda Pharmaceutical Company Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Danny Stepto, Takeda Pharmaceuticals International GmbH,
TEL: +41-44-555-1504, Danny.Stepto@takeda.com. Takeda Pharmaceutical
Company, Corporate Communications Dept. (PR/IR), TEL:
+81-3-3278-2037.