Navigation Links
Takeda Submits Biologics License Application for a New Investigational Drug Vedolizumab, in Moderately to Severely Active Crohn's Disease and Ulcerative Colitis in the United States
Date:6/21/2013

DEERFIELD, Ill. and OSAKA, Japan, June 21, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a Biologics License Application (BLA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for vedolizumab, an investigational humanized monoclonal antibody for the treatment of adults with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD).

"The disease burden of IBD is quite significant in the United States, especially on the many young adults living with Crohn's disease and ulcerative colitis," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "This regulatory submission marks a significant step forward for vedolizumab in the U.S., and as a company we are excited about the possibility of providing this community with a new treatment option."

More than four million people worldwide are affected by IBD, with CD affecting as many as 700,000 people and UC affecting as many as 700,000 people in the U.S. Crohn's disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract. Inflammation caused by CD can involve all areas of the digestive tract, while UC typically impacts the colon and rectum. CD and UC can be both painful and debilitating, which may sometimes lead to serious complications. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.  

"CD and UC are chronic diseases that can negatively impact those who live with the associated challenges – and the need to seek
'/>"/>

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Takeda Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone), Are Now Available in Pharmacies in the United States
2. AGA Research Foundation Announces Endowment Gift from Takeda Pharmaceuticals U.S.A., Inc. to Support Gastroenterology Research
3. Takeda to Acquire Inviragen, Inc.
4. Takeda Responds to Verdict in Diabetes Drug Case
5. Takeda Launches New Subsidiary in Ecuador
6. Takeda lanza nueva subsidiaria en Ecuador
7. Scripps Research Institute and Takeda Pharmaceuticals Announce Expanded Research Collaboration
8. Takeda presenta la richiesta di autorizzazione allimmissione in commercio nellUnione Europea per Vedolizumab nella colite ulcerosa moderata-grave e nella malattia di Crohn
9. Takeda Submits Marketing Authorisation Application for Vedolizumab in Moderately to Severely Active Ulcerative Colitis and Crohns Disease in the European Union
10. Takeda and Resolve Therapeutics Enter Autoimmune Partnership
11. Takeda Receives FDA Approval for Three New Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... Sept. 19, 2014 The American Association for ... Design and Manufacturing has joined the AAHomecare Corporate Partner ... Harvey Diamond have been actively involved in AAHomecare ... it has quickly grown into a major global manufacturer ... Drive allows AAHomecare to increase efforts on behalf of ...
(Date:9/19/2014)... Larry J. Merlo , President and CEO ... before the National Press Club in Washington, D.C. ... to stop selling tobacco products and its leadership in driving ... "Dramatic changes in our health care system pose enormous ... has said. "CVS Health has a truly unique combination of ...
(Date:9/19/2014)... Sept. 19, 2014  Lpath, Inc. (NASDAQ: ... lipid-targeted therapeutics, announced today that it has entered ... of common stock and 3,605,042 unregistered warrants in ... for one registered share of common stock and ... of common stock will be $3.475.  The warrants ...
Breaking Medicine Technology:Drive Medical Design & Manufacturing Joins AAHomecare Corporate Partner Program 2CVS Health CEO to Address National Press Club on Landmark Decision to Quit Tobacco, Leadership in Health Care Innovation 2CVS Health CEO to Address National Press Club on Landmark Decision to Quit Tobacco, Leadership in Health Care Innovation 3Lpath, Inc. Announces $12.5 Million Registered Direct Offering 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 3
... Endosurgery, Inc. announced that their newly-launched OverStitch™ Endoscopic ... first-in-human cases. OverStitch ... mimics the way physicians deploy sutures by hand.  It ... surgical standard of care through the flexible endoscope.   ...
... Oct. 28 The U.S. Food and Drug ... the treatment of adults with schizophrenia. ... http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) Schizophrenia affects ... 18 years and older, in a given year. ...
Cached Medicine Technology:Apollo Endosurgery Completes First-in-Human Cases With New OverStitch™ Endoscopic Suturing System 2FDA Approves Latuda to Treat Schizophrenia in Adults 2
(Date:9/19/2014)... September 19, 2014 -- Recent two-generation approaches to ... are receiving increasing attention from researchers, advocates, and ... to enable them to move to jobs that ... early care and education for children, these programs ... However, according to a new report from ...
(Date:9/19/2014)... As summer vacations end and everyone returns ... now reminds area patients about the reality and impact of ... affected by gum disease, there is simply not an option ... years Dr. Krishnan has treated patients with varying degrees of ... that come in due to common symptoms such as bleeding ...
(Date:9/19/2014)... (PRWEB) September 19, 2014 Recently, ... and announced that JustHost, IX Web Hosting and ... , “As is known to most people, ... partitioning a physical server computer into many servers, ... of running on someone’s own dedicated computer,” the ...
(Date:9/19/2014)... are notoriously difficult to study with X-ray crystallography, not ... impossible, to crystallize, but also because their very nature ... when a structure can be obtained it is often ... of protein domains that sometimes create more puzzles than ... Cryst . D70, 2241-2255; doi: 10.1107/S1399004714016496 ] , ...
(Date:9/19/2014)... 2014 Top10BestSEOHosting.com today compares many ... HostMonster, Arvixe and Bluehost are the best suppliers ... quality WordPress hosting (including VPS and cloud hosting) ... more detailed information. , HostMonster ( http://www.hostmonster.com/track/seohosts ) ... at a fraction of the cost. As a ...
Breaking Medicine News(10 mins):Health News:A two generation lens: Current state policies fail to support families with young children 2Health News:New York Periodontist Dr. Prabha Krishnan Now Raises Awareness about the Dangers of Untreated Decay, Gingivitis and Gum Disease During Self-Awareness Month 2Health News:New York Periodontist Dr. Prabha Krishnan Now Raises Awareness about the Dangers of Untreated Decay, Gingivitis and Gum Disease During Self-Awareness Month 3Health News:Top10BestSEOHosting.com: JustHost is One of the Best VPS Suppliers in 2014 2Health News:A refined approach to proteins at low resolution 2Health News:A refined approach to proteins at low resolution 3Health News:Top10BestSEOHosting.com: They Are Best Windows Web Hosting Suppliers Of 2014 2
... The international team of researchers from the United States and ... both assassin and messenger. This led to the // race ... cell. Cells that could seek out and destroy cancer have ... the Seraph Professor of Oncology at the Johns Hopkins Kimmel ...
... College of Georgia said that genes that control blood pressure ... on more than 500 pairs of black and // white ... that changes in gene expression between ages 14 and 18 ... variation that occurred by age 18. The results were presented ...
... in matters of sleep till late the reason being ... ray of new light comes the IST project 'Sensation' ... different // countries, addressing sensing of physiological parameters, core ... a multipurpose sensing platform consisting of 17 micro sensors ...
... in Mumbai were crippled as the striking doctors were determined ... dry. All the government hospitals in Mumbai suffered due to ... from 15 government-managed hospitals in this bustling city of over ... 27, demanding better security while on the job after relatives ...
... A research has found out that a sudden emotional stress ... beloved ones or failure// in romance are said to be ... ,Researchers at Johns Hopkins University found that shock could ... attack causing severe heart muscle weakness, reported health portal Health ...
... Center researchers have discovered that distinct regions of the ... ambiguous choices versus// choices involving only risk. The investigators ... and how such risk-taking can become an addition or ... in the journal Neuron. ,The research was ...
Cached Medicine News:Health News:Two in One Cell Offers Hope to Find a Cure for Cancer 2Health News:Genetic Reasons behind Change in One’s Blood Pressur 2Health News:Sleep Science awakens from deep slumber! 2Health News:Health Services Came To A Halt As Mumbai Doctors Strike Continues 2Health News:Distinct Brain Sections Are Activated While Making Risky Decisions 2
... has been selling replacement bulbs ... and we are extremely proud ... Check out our catalog of ... discount light bulbs specials. ...
... Bulb Direct has been ... Internet since 1996, and we ... 100% satisfaction guarantee. Check out ... and see our discount light ...
... has been selling replacement bulbs ... and we are extremely proud ... Check out our catalog of ... discount light bulbs specials. ...
... been selling replacement bulbs on ... we are extremely proud of ... out our catalog of replacement ... light bulbs specials. ,Check ...
Medicine Products: