Navigation Links
Shire plc: Lialda® (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
Date:7/18/2011

PHILADELPHIA, July 18, 2011 /PRNewswire/ --


 

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda® (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild to moderate ulcerative colitis.

"At Shire, we strive to create meaningful therapies for patients with our clinical programs, and this approval based on our large clinical trial underscores our commitment and dedication to the ulcerative colitis community," said Roger Adsett, Senior Vice President of Shire's Gastrointestinal business. "This new indication is an important milestone for Lialda as it provides a once-daily option for both inducing remission in patients with active, mild to moderate ulcerative colitis and maintaining remission of ulcerative colitis."  

Lialda's new indication is based on results from a multicenter, randomized, double-blind, active comparator, non-inferiority study conducted in 826 adult patients in remission from ulcerative colitis. Maintenance of remission was assessed using a modified Ulcerative Colitis Disease Activity Index (UC-DAI) and was based on maintaining endoscopic remission defined as a modified UC-DAI endoscopy subscore of less than or equal to 1. The endoscopy subscore of less than or equal to 1 represented normal or mild disease with no friability.

Of the patients receiving Lialda 2.4 g/day (n=343) administered once daily, 83.7% maintained remission at Mon
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Shire plc : Second Quarter 2011 Results Date Notification - July 28, 2011
2. Shire Files Lawsuits Against Sandoz and Amneal for Infringement of VYVANSE® (lisdexamfetamine dimesylate) Patents
3. United Lincolnshire Hospitals NHS Trust Selects Jayex QI Interactive Patient Survey and Information Management Kiosk
4. Shire Completes Acquisition of Advanced BioHealing, Inc.
5. European Authorities Approve New Manufacturing Facility for Shires REPLAGAL® (agalsidase alfa)
6. Prasco Announces Agreement with Shire for Future Exclusive Distribution and Supply of Authorized Generic for PENTASA®
7. Shire Recognized by ISPE Facility of the Year Awards Program
8. Reportlinker Adds Shire plc: PharmaVitae Profile
9. Shire Presents Positive New Data at the 60th Annual American Society of Human Genetics (ASHG) for Patients with Type 1 Gaucher Disease
10. Shire plc: Third Quarter 2010 Results Date Notification - October 29, 2010
11. Atrium Recognized by New Hampshire Bio/Medical Council
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... THOUSAND OAKS, Calif. , Jan. 15, 2014 ... and Amgen (NASDAQ: AMGN ) announced ... to jointly discover and validate new therapeutic targets ... (IBD), a chronic disorder that affects millions worldwide. ...
(Date:1/15/2014)... 2014  Manufacturers, suppliers and distributors of innovative medical-related ... their most important business assets, intellectual property (IP). ... Because of the highly-competitive nature of the ... the most litigious industry sectors of cases involving ...
(Date:1/15/2014)... 15, 2014  Echo Therapeutics, Inc. (Nasdaq: ECTE ... CGM System as a non-invasive, wireless continuous glucose monitoring ... Executive Chairman and Interim CEO of Echo Therapeutics, will ... Equity Conference. Mr. Doman will make ...
Breaking Medicine Technology:Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4Intellectual Property Insurance for Medical-related Products and Services 2Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 2Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 3
... The Rogosin Institute is bringing dialysis closer to ... new dialysis center in Auburndale, Queens. The Opening Reception, ... Marshall, Queens Borough President, Paola Miceli, Director, Health, Human ... can accommodate 232 patients. In addition to dialysis, the ...
... 13, 2011 Today, Gil Kerlikowske, Director of National ... of Mothers Against Drunk Driving (MADD) announced a new ... drugged driving.  MADD has launched a national effort to ... and drugs) and drugged driving, and to recognize law ...
Cached Medicine Technology:The Rogosin Institute Opens New Dialysis Center in Queens 2White House Drug Policy Director and Mothers Against Drunk Driving Unite to Combat Drugged Driving; Call on Parents to Act to Reduce Significant Public Safety Threat 2White House Drug Policy Director and Mothers Against Drunk Driving Unite to Combat Drugged Driving; Call on Parents to Act to Reduce Significant Public Safety Threat 3
(Date:4/17/2014)... Experimental Biology and Medicine a multidisciplinary research ... Kenis in the Institute of Genomic Biology (IGB) ... Urbana-Champaign describe their recent work on subcellular redox ... cell functions including energy metabolism, signaling, and transcriptional ... normal cellular behavior, redox status has been recognized ...
(Date:4/17/2014)... has created a new technology for modifying human ... the body and selectively target cancer and other ... that monitor and modify human physiology is a ... existing technology enabled bioengineers to build such devices ... in a customized fashion. , "The project addressed ...
(Date:4/17/2014)... 17, 2014-- Colic affects about one in five infants ... pediatric visits during the first several months after birth. ... was showing promise; however, the April 1, 2014 issue ... Valerie) reported on a study, "Probiotics and Infant Colic," ... reuteri for infant colic did not reduce ...
(Date:4/17/2014)... off depression among retirees, particularly among those who live ... The Journals of Gerontology, Series B: Psychological Sciences and ... Use and Depression Among Retired Older Adults in the ... that Internet use reduced the probability of a depressed ... , Late-life depression affects between 5 and 10 million ...
(Date:4/17/2014)... therapy improves general blood flow and alleviates muscle ... researchers at the University of Illinois at Chicago. ... print in the Archives of Physical Medicine ... vascular function in people who had not exercised, ... of their level of physical activity. , Improved ...
Breaking Medicine News(10 mins):Health News:Live cell imaging reveals distinct alterations of subcellular glutathione potentials 2Health News:Building 'smart' cell-based therapies 2Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2Health News:Internet use may cut retirees' depression 2Health News:Massage therapy improves circulation, eases muscle soreness 2
... anti-reservation medicos strike in India, the government on Sunday night ... on quota in central educational institutes// but the students and ... by calling a bandh in Delhi on May 31. ... talks with Federal Minister Oscar Fernandes who followed it up ...
... attractive destination for conducting global clinical trials due to ... trained medical professionals and sophisticated technological infrastructure. // ... valued at Rs 3.1 billion in 2005 and is ... Most of the US and European nations are outsourcing ...
... Scientists in the US have created an artificial penis ... and may one day help treat men with severe ... Atala and colleagues at the Wake Forest Institute for ... new method of tissue engineering, reported the online edition ...
... city of Faisalabad have been affected by contaminated water, an ... victims of water-borne diseases, which broke out as a result ... to further increase as more people are being hospitalized., ... affected area is also underway. , ,'we have taken ...
... resolve of the students against reservations who continue their stir ... students tried to self immolate themselves - one in the ... whom the police described as a vendor, tried immolating himself ... gathered in strength, staged a rally protesting against the government's ...
... Geneva - The new interim head of the World Health ... first time since assuming office // , confirmed that Dr ... resources and the support from the people to continue the ... that he would continue the work of his predecessor Dr ...
Cached Medicine News:Health News:Two Students Try To Self-Immolate As Anti-Quota Stir Continues 2Health News:Two Students Try To Self-Immolate As Anti-Quota Stir Continues 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: