Navigation Links
Takeda Submits Marketing Authorisation Application for Vedolizumab in Moderately to Severely Active Ulcerative Colitis and Crohn's Disease in the European Union
Date:3/7/2013

OSAKA, Japan, March 7, 2013 /PRNewswire/ --

Takeda Pharmaceutical Company Limited ("Takeda") today announced that a Marketing Authorisation Application (MAA) has been submitted to The European Medicines Agency (EMA) for vedolizumab, an investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), the two most common types of inflammatory bowel disease (IBD). If approved, vedolizumab would be the first and only gut-selective biologic agent for UC and CD on the market.

"Ulcerative colitis and Crohn's disease are chronic debilitating diseases with important unmet medical needs, often affecting young people in the prime of their lives," said Asit Parikh , M.D., Ph.D., vice president, general medicine, Takeda. "We are encouraged by the findings of GEMINI, the vedolizumab Phase 3 clinical development program, which studied approximately 3,000 patients in nearly 40 countries, making it the largest IBD clinical trial program conducted to date."

Nearly four million people worldwide are affected by IBD, with UC affecting more than 500,000 people and CD affecting approximately 230,000 people in the EU.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 varying areas of the digestive tract, while UC impacts the colon only.CD and UC can be both painful and debilitating, which may sometimes lead to serious complications and can significantly impact the quality of life for patients.

The MAA submission was supported by Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which are part of the GEMINI Studies™, a four-study clinical research program to investigate the efficacy and safety of vedolizumab on clinical response and remission
'/>"/>

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

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Takeda and Resolve Therapeutics Enter Autoimmune Partnership
2. 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)
3. FDA Accepts Takeda and Lundbecks Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder
4. Takedas Deerfield Campus Ranked Among Chicagos Top 100 Workplaces in 2012
5. Takeda Completes its Russian Pharmaceutical Manufacturing Facility
6. Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
7. Zacks Bull and Bear of the Day Highlights: Discover Financial Services, POSCO, AstraZeneca, Bayer and Takeda Pharmaceutical
8. Takeda to Acquire Multilab, Enhancing its Business Infrastructure in Brazil
9. Taiho Pharmaceutical Submits Application for Approval to Manufacture and Market Novel Antitumor Agent TAS-102
10. Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
11. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... , 21. Mai 2013 ... die die Firmen OMNIlife science® Inc., Enztec Ltd. ... hat zwei neue, erfahrene Mitglieder in die ... , eine erfahrene Führungspersönlichkeit aus der Orthopädie, ... David Johnson , anerkannter Experte ...
(Date:5/21/2013)... CEO of Mammotome, a division of Devicor Medical Products, has ... Cincinnati chapter of the Association for Corporate Growth ... who is also a breast cancer survivor, led the purchase ... 2010. Daulton will be presented with the award at the ... May 22. The ACG Deal Maker Awards program ...
(Date:5/21/2013)... and PHILADELPHIA , May 21, 2013 ... its new corporate image and impressive new product developments at ... . "After ten years of unerring focus on product ... felt the need to mark the occasion," said founding director ... we have some interesting developments of benefit to our clients ...
Breaking Medicine Technology:Orthopaedic Synergy Inc. meldet bedeutenden Zuwachs im Vorstand 2Orthopaedic Synergy Inc. meldet bedeutenden Zuwachs im Vorstand 3Tom Daulton, Mammotome CEO, Named ACG Dealmaker of the Year 2Tom Daulton, Mammotome CEO, Named ACG Dealmaker of the Year 3Pi2 Solutions' 10th Anniversary Heralds New Corporate Image as Platinum Sponsor of SLA PHT Meeting in Philadelphia 2Pi2 Solutions' 10th Anniversary Heralds New Corporate Image as Platinum Sponsor of SLA PHT Meeting in Philadelphia 3
... As the diverse areas of healthcare forge ... must medical technologies reform to solve several challenges ... and restraints into an interpretable roadmap, Frost & ... and Outcomes-Oriented Healthcare Delivery, 2010 to 2012 ...
... 2012 Tarsa Therapeutics today announced it has entered ... the bulk manufacture of its OSTORA™ oral recombinant salmon ... in QS Pharma,s state-of-the-art facility in Pennsylvania, will be ... This new agreement builds on the continuing collaboration between ...
Cached Medicine Technology:Frost & Sullivan's Advanced Medical Technologies Research Tracks Opportunities in Markets Influenced by Dynamic Care Pathways 2Frost & Sullivan's Advanced Medical Technologies Research Tracks Opportunities in Markets Influenced by Dynamic Care Pathways 3Tarsa Therapeutics Signs Commercial Supply Agreement for its Ostora™ Oral Calcitonin Product With QS Pharma 2Tarsa Therapeutics Signs Commercial Supply Agreement for its Ostora™ Oral Calcitonin Product With QS Pharma 3
(Date:5/21/2013)... (PRWEB) May 21, 2013 Standard advice ... test-drive and little else. However given industry’s less than ... to shoppers via the internet, Consumer Mattress Reports sets ... “ Choosing The Best Mattress .” , This article ... tips and suggestions that may not be readily apparent ...
(Date:5/21/2013)... Allen, TX (PRWEB) May 21, 2013 ... honored with the prestigious 2013 Top-Rated Award by GreatNonprofits ... , “We are excited to be named a Top-Rated 2013 ... happen without the dedication of our over 3000 Volunteers and ... is especially significant as it came from those that have ...
(Date:5/21/2013)... May 21, 2013 Parker Waichman LLP, a ... injured by defective medical devices, is offering remarks on the ... the Estate of Fred E. Taylor v. Intuitive Surgical, 09-2-03136-5, ... May 21, 2013, Bloomberg report noted that the ... a “car dealership” in how it deployed its strategy to ...
(Date:5/21/2013)... TX (PRWEB) May 21, 2013 ContinuCare ... the Texas Department of Aging and Disability Services. After ... and employee interviews, ContinuCare Home Health was found ... The review is part of the Department of Aging ... of aging and disability services, supports and opportunities ...
(Date:5/21/2013)... May 21, 2013 HealthSmart continues to ... national presence has required the hiring of new talent ... is pleased to announce that Dawn Powell has joined ... as the Director of Account Management in the Central ... in Irving, Texas. With extensive client management, employee benefits, ...
Breaking Medicine News(10 mins):Health News:Choosing the Best Mattress Simplified in Consumer Mattress Reports’ Latest Article 2Health News:Medical Ministry International Recognized as a 2013 Top-rated Nonprofit By GreatNonprofits.org 2Health News:Da Vinci Robotic Surgery Lawsuit: Parker Waichman LLP Reacts to Plaintiff’s Attorney’s Closing Argument in Which He Describes Intuitive Surgical as a Car Dealership 2Health News:Da Vinci Robotic Surgery Lawsuit: Parker Waichman LLP Reacts to Plaintiff’s Attorney’s Closing Argument in Which He Describes Intuitive Surgical as a Car Dealership 3Health News:ContinuCare Home Health, Inc. Receives Perfect Report from the Texas Department of Aging and Disability Services 2Health News:New Talent Joins the HealthSmart Account Management Team 2
... of the American College of Cardiology during,ceremonies at ... in Chicago, CHICAGO, April 1, 2008 ... Bluhm Cardiovascular Institute,of Northwestern Memorial Hospital, and Goldberg ... was recognized by the,American College of Cardiology (ACC) ...
... Leading consumer,employer and labor organizations today announced ... and health insurers on principles,to guide how ... the,information to consumers., The "Patient Charter ... announced today creates a national set of ...
... from people up to 75 had similar survival rates to ... News) -- People up to the age of 75 should ... National Eye Institute-funded study. , The researchers found that tissue ... success rate (86 percent) as corneas from donors aged 12 ...
... Your friend can eat whatever she wants and still fit into ... look at that chocolate cake. Before you sign up for Weight ... at some recent research from Tel Aviv University and save yourself ... to do with rigorous exercise and abstaining from sweets than it ...
... A new study has found that an x-ray dye ... prevent renal injury during percutaneous coronary intervention (PCI) in ... it made no difference in the need for dialysis ... the Contrast Media and Nephrotoxicity Following Coronary Revascularization by ...
... Speaker Denny Chipollini inspires others to hit the trails for ... Valley Forge Revolutionary 5-mile ... most people would,consider tragedies, 55-year-old Skippack, Pa., resident Denny Chipollini,considers ... loss of his leg in a near-fatal car accident and ...
Cached Medicine News:Health News:Robert Bonow, MD Honored for Outstanding Service by the American College of Cardiology 2Health News:Robert Bonow, MD Honored for Outstanding Service by the American College of Cardiology 3Health News:Consumers, Health Care Purchasers, Physicians, and Health Insurers Announce Agreement on Principles to Guide Physician Performance Reporting 2Health News:Consumers, Health Care Purchasers, Physicians, and Health Insurers Announce Agreement on Principles to Guide Physician Performance Reporting 3Health News:Consumers, Health Care Purchasers, Physicians, and Health Insurers Announce Agreement on Principles to Guide Physician Performance Reporting 4Health News:Consumers, Health Care Purchasers, Physicians, and Health Insurers Announce Agreement on Principles to Guide Physician Performance Reporting 5Health News:Study Finds Older Corneas Suitable for Transplantation 2Health News:The lean gene 2Health News:Iso-osmolar X-ray dye falters in PCI study 2Health News:Iso-osmolar X-ray dye falters in PCI study 3Health News:For Inspiring Amputee It's No Excuses, No Limits 2
Cannulated Interference Screws...
... Cannulated Interference Screws. ... strength and graft selection ... easily without deformation, and ... full threaded atraumatic tissue ...
... Mini-TrueView Arthroscopes,Based on the TrueView II design, ... optic telescopes for small joint arthroscopy is ... autoclavable and very durable thanks to Olympus ... new telescope class means bright images, brilliant ...
... The SOVEREIGN System offers new WHITESTAR Technology, ... phaco. WHITESTAR Technology dramatically reduces the amount ... while still providing full ultrasound cutting efficiency. ... fragments are drawn safely and efficiently to ...
Medicine Products: