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

new treatment options is well-recognized," said William J. Sandborn, M.D., chief, division of gastroenterology & professor of medicine, University of California San Diego School of Medicine. "In clinical development, vedolizumab has demonstrated the potential to be another possible treatment option for people with moderately to severely active CD and UC."

The BLA submission was supported by the Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which make up the GEMINI Studies™, a four-study clinical program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients. Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators and/or a TNF-alpha antagonist. TNF-alpha antagonist failure patients included those with inadequate response (primary nonresponders), loss of response (secondary nonresponders) or those who were intolerant. Vedolizumab has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both CD and UC.

GEMINI I was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active UC in whom one prior therapy had failed. Key primary endpoints included clinical response at week six and clinical remission at week 52.

GEMINI II was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active CD. Primary outcomes included the number of patients in clinical remission and enhanced clinical response at week six, and clinical remission at 52 weeks.

GEMINI III was designed to assess the efficacy and safety of vedolizumab
'/>"/>

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:4/27/2015)... , April 27, 2015  CryoLife, Inc. (NYSE: ... processing company focused on cardiac and vascular surgery, announced ... the United States Food and Drug Administration ("FDA") verifying ... in place following the warning letter it received from ... letter follows a re-inspection in March 2015 by the ...
(Date:4/27/2015)... Va. and WASHINGTON , ... Specialty Pharmacy (NASP) and SmartBrief recently partnered to deliver ... a snapshot of the top news in the industry. ... pharmacies, pharmaceutical and biotechnology manufacturers, GPOs, distributors and other ... resource will launch on April 27, 2015. ...
(Date:4/27/2015)... Demonstrating the power of partnership within the medtech community, ... produce a world class medical technology conference in conjunction ... 2015, at the Minneapolis Convention ... combined 2015 Minneapolis event is expected to bring in ... under one roof, offering a great networking opportunity for ...
Breaking Medicine Technology:CryoLife Announces Resolution of FDA Warning Letter 2NASP and SmartBrief Partner on Specialty Pharmacy SmartBrief 2LifeScience Alley and MD&M Minneapolis partner for Minnesota Medtech Week 2LifeScience Alley and MD&M Minneapolis partner for Minnesota Medtech Week 3
... , LAKE FOREST, Ill., Dec. 23 ... specialty pharmaceutical and medication delivery company, today announced that the ... Conference on Wednesday, Jan. 13, 2010, in San Francisco. , ... time on Wednesday, Jan. 13, 2010. It will be ...
... ... was marked by an abundance of media coverage and attention ... Hollywood. Over the past 12 months, several high-profile celebrities ... Lohan and, Courtney Love, while autopsies for Michael Jackson, Anna ...
Cached Medicine Technology:The Waismann Method Reflects on 2009: The Year of the Prescription Painkiller 2The Waismann Method Reflects on 2009: The Year of the Prescription Painkiller 3The Waismann Method Reflects on 2009: The Year of the Prescription Painkiller 4
(Date:4/28/2015)... “ Gwee ” was featured on ... features the latest and coolest technology products available to ... for NewsWatch, conducted the review and shared with viewers ... As much as everyone loves their tablets, it’s annoying ... looking at them, it's even more annoying trying to ...
(Date:4/28/2015)... The Awareness Counselor team has introduced a new and ... to Awareness Counselor, there are ramifications of judging. Judging can ... an individual who self-judges. This new concept is now being ... one one one talk. , The premise of this new ... every being on earth is here for a purpose and ...
(Date:4/28/2015)... 28, 2015 According to Professor Donald ... (June 27, 2014), prescription drugs are the fourth ... is becoming increasingly aware of the limitations and dangers ... as chemotherapy drugs to treat cancer, Prozac for depression ... evolving to become increasingly resistant to current drugs and ...
(Date:4/28/2015)... Cruz, California (PRWEB) April 28, 2015 ... in premium, healthy, and convenient nutrition for ... of its distribution through United Natural Foods ... of natural, organic and specialty foods including ... now be available to thousands of retailers ...
(Date:4/28/2015)... Livermore, CA (PRWEB) April 28, 2015 ... safety services, today announced the relocation of their Southern ... Their move to 9380 7th Street, Unit I (letter ... 2015. , This relocation was necessitated by the significant ... years in Southern California. PREVENT will continue to provide ...
Breaking Medicine News(10 mins):Health News:The Most Innovative iPad Case was Featured on NewsWatch Television 2Health News:What Happens When We Judge Ourselves and Others? – A New Concept Introduced 2Health News:What Happens When We Judge Ourselves and Others? – A New Concept Introduced 3Health News:Trivedi Science™ Announces the Beginning of Their Science Research to Create Highly Effective Pharmaceutical Drugs with Minimal Side Effects 2Health News:Trivedi Science™ Announces the Beginning of Their Science Research to Create Highly Effective Pharmaceutical Drugs with Minimal Side Effects 3Health News:Trivedi Science™ Announces the Beginning of Their Science Research to Create Highly Effective Pharmaceutical Drugs with Minimal Side Effects 4Health News:LifeAID Beverage Co. Announces Expanded Distribution Roll Out Through UNFI -- United Natural Foods Inc. 2Health News:LifeAID Beverage Co. Announces Expanded Distribution Roll Out Through UNFI -- United Natural Foods Inc. 3Health News:PREVENT Life Safety Moves to New Office in Rancho Cucamonga 2
... /PRNewswire-FirstCall/ - MDS Inc. (TSX: MDS; NYSE: MDZ ), a ... today reported financial results and filed its unaudited interim consolidated financial statements ... January 31, 2010 . In order to simplify our disclosures, we have ... ...
... ... , ... ... ST. PAUL, Minn. , March 16 The ...
... ... ... -- PCU College of Holistic Medicine has re-launched its website thanks to the growth of ... as the school’s main presence on the Internet, and school officials are confident that the ...
... Scrubbers with ... , ... 16, 2010 -- A new case study from Advance tells how Washington High School ... staph infection in the school’s gymnasium. Many cleaning and maintenance departments are finding that ...
... , ... Children’s Health Council leads clinical research for local patients , ... Palo Alto, CA (PRWEB) March 16, 2010 -- Autism is ... and communication, in addition to restricted, repetitive behaviors. Once considered quite rare, 1 in ...
... ... by Joe Edwards in 1979, it is now led by his daughter Carla Edwards and ... serving the local Savannah community along with all of Georgia and South Carolina.” , ... Savannah, GA (PRWEB) March 16, 2010 ...
Cached Medicine News:Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 2Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 3Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 4Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 5Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 6Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 7Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 8Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 9Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 10Health News:MDS Reports First Quarter Fiscal 2010 Financial Results 11Health News:Minnesota Coalition for Kids Health Coverage Launches HealthyKidsMN.org 2Health News:Minnesota Coalition for Kids Health Coverage Launches HealthyKidsMN.org 3Health News:Minnesota Coalition for Kids Health Coverage Launches HealthyKidsMN.org 4Health News:Minnesota Coalition for Kids Health Coverage Launches HealthyKidsMN.org 5Health News:PCU College of Holistic Medicine Launches New Website 2Health News:Flexible Floor-Cleaning Routine Helps School Prevent Spread of Infection 2Health News:Flexible Floor-Cleaning Routine Helps School Prevent Spread of Infection 3Health News:Flexible Floor-Cleaning Routine Helps School Prevent Spread of Infection 4Health News:Autism Research Study Announced By Children's Health Council 2Health News:Savannah, Georgia, Insurance Agency Celebrates Over 30 Years of Service 2Health News:Savannah, Georgia, Insurance Agency Celebrates Over 30 Years of Service 3
Tapered Shaft Microscissors : Williams Curved SharpTipped Scissors...
Disposable Microscissors: Horizontal, Curved...
Disposable Microscissors: Horizontal, Straight...
Disposable Microscissors: Vertical, 90...
Medicine Products: