Navigation Links
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 Month 6, which was similar to that seen
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. New Analyses of Long-Term LIALDA(TM) (mesalamine) Data Presented at ACG
2. New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Colitis Patients
3. Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis
4. Analysis of Ulcerative Colitis (UC) Time to Symptom Resolution Data from Pivotal Study of LIALDA(TM) (mesalamine) Presented at DDW
5. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
6. Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets
7. Shire Presents Results of Five Lialda(R) (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting
8. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
9. Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
10. Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
11. Nexavar First FDA-Approved Drug Therapy for Liver Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/27/2014)... , Nov. 27, 2014 ... to Academic Research - JIN Co., Ltd. will ... a market price of 500,000 yen or $5,000 (without tax ... software). The "ACADEMIC PACK" is a dedicated solution of "JINS ... capture and analyze deep data* generated by electrooculography and six-axis ...
(Date:11/26/2014)... -- Cohen, Placitella & Roth, PC is investigating potential ... Pharmaceutical Corporation ("Nymox" or "Company") (NASDAQ: ... 2011 through November 2, 2014 ("Class Period").  The ... officers and directors publically disseminated materially false and/or ... 20(a) of the Securities Exchange Act of 1934 ...
(Date:11/26/2014)... Md. , Nov. 26, 2014  Over 100 ... of those suffer from this pain daily. Chronic and ... of pain management is born to fulfill the need ... all types of pain. On October 28th, ... the Cumberland, Maryland community.  This ...
Breaking Medicine Technology:JIN to Launch JINS MEME ACADEMIC PACK in Late April 2015 2JIN to Launch JINS MEME ACADEMIC PACK in Late April 2015 3Cohen, Placitella & Roth, PC Investigating Nymox Pharmaceutical Corporation for Failing to Disclose Material Information 2Cohen, Placitella & Roth, PC Investigating Nymox Pharmaceutical Corporation for Failing to Disclose Material Information 3New Pain Management Center Opens in Cumberland, Md. 2
... Inc. (NYSE: MTD ) today announced the webcast ... in New York on Wednesday, September 21, 2011, at 9:00 ... presentation, visit the investor relations page on the Company,s Web ... will be available for seven days. METTLER TOLEDO ...
... Micross Components, a leading global provider of ... Manager of its US Products & Services Division. ... business development, will play a leading role in ... to increase market share across several key business ...
Cached Medicine Technology:Micross Components Names Mike Deley as General Manager of US Products & Services Division 2
(Date:11/27/2014)... TORQ Cycle is not only know for their highly ... the way to help their customers but also for their ... their workouts sincerely using indoor cycling . They have ... is important for people to take their fitness quite seriously. ... that people take to fitness and are encouraged to work ...
(Date:11/27/2014)... Let the Black Friday sales begin at Sublime Beauty®! ... filled with skincare goodies, will delight and please her on ... last - no coupon required. See the gift ... Amazon at the same sales prices. Links to the Amazon ... ease. , The company published a 2014 Gift Guide ...
(Date:11/27/2014)... 2014 Luciana Lagana and her ... of Omadox, a feature film that received 9 awards at ... best ensemble cast. It is also an official selection of ... to a successful cinematic career for James Noel, a young ... you enjoy experimental mystery, filmed in glorious black and white, ...
(Date:11/27/2014)... Blood-borne pathogens raise the risk of spreading ... in place to counter this. However, it doesn’t seem ... with menstrual blood are taken as seriously. , ... way to handle tampons and menstrual pads while also ... , He then created a prototype of the Sani-M, ...
(Date:11/27/2014)... York, New York (PRWEB) November 27, 2014 ... ) have been filed in a consolidated ... Liebhard LLP reports. , Documents recently updated ... 1,079 records included in the state proceeding, all ... schizophrenia, bipolar disorder and other psychiatric conditions. Many ...
Breaking Medicine News(10 mins):Health News:The new wave in Fitness : Stay Active with Innovative Indoor Cycling Programs 2Health News:Big Christmas Sales Begin Today at Sublime Beauty® for all Christmas Gift Selections and Skincare Sets 2Health News:Luciana Lagana and Gregory Graham Join the Award-Winning Cast of the Black-and-White Experimental Mystery Feature Film Omadox. 2Health News:Luciana Lagana and Gregory Graham Join the Award-Winning Cast of the Black-and-White Experimental Mystery Feature Film Omadox. 3Health News:New Risperdal Lawsuits Added to Philadelphia Litigation, Bernstein Liebhard LLP Reports 2Health News:New Risperdal Lawsuits Added to Philadelphia Litigation, Bernstein Liebhard LLP Reports 3Health News:New Risperdal Lawsuits Added to Philadelphia Litigation, Bernstein Liebhard LLP Reports 4
... study finds , , WEDNESDAY, March 4 (HealthDay News) -- ... with accompanying commercials for alcohol were more apt to grab ... to those who watched a movie without the drinking prompts. ... effect of on-screen depictions of alcohol and their influence on ...
... Growth From World,s Largest EconomyMISSISSAUGA, ON, March 4 /PRNewswire-FirstCall/ ... developing drug free, non-invasive low level laser and light ... that the company has received CE Mark approval to ... light products in all 25 European Union (EU) and ...
... and their dogsNEW YORK, March 4 ... initiative to help dogs and their owners become more fit ... enjoy the benefits their dogs bring to their lives, the ... further this enjoyment. The "Walk Your Dog, Make Life ...
... advanced telemedicine program in the state, proven to ... and improve patient outcomesANCHORAGE, Alaska, March 4, 2009 ... new program to enhance care of the critically ... eICU(R) Program, patented by Philips VISICU, combines early ...
... Kournikova has just returned from her first visit ... effects of years of poverty, violence and natural ... (Photo: http://www.newscom.com/cgi-bin/prnh/20090304/DC78519 )"It was ... said Kournikova, following her visit. "This trip ...
... as Co-Founder of MISSION Skincare(TM) NEW YORK, March 4 ... Athlete-Engineered Skincare(TM) products, is pleased to announce that champion ... Skincare(TM) products are designed and tested by the world,s ... training and competition as well as the everyday needs ...
Cached Medicine News:Health News:Media Images of Alcohol Can Drive You to Drink 2Health News:MedX Health Receives CE Mark for Laser & Light Products 2Health News:MedX Health Receives CE Mark for Laser & Light Products 3Health News:Shape Partners With Iams to Create Healthy Living Program 'Walk Your Dog, Make Life Better' 2Health News:eICU(R) Program Activates in Alaska 2Health News:eICU(R) Program Activates in Alaska 3Health News:PSI Brings Tennis Star Anna Kournikova to Haiti Bringing Hope and Assistance to Child Slaves 2Health News:PSI Brings Tennis Star Anna Kournikova to Haiti Bringing Hope and Assistance to Child Slaves 3Health News:Sergio Garcia Has a New 'MISSION' 2
Tungsten Carbide wire twister....
Large solid mallet with patented Ortho-Grip® silicone rubber handle....
Straight chisel for scoring, cutting, scraping, cleaning and sculpting bone....
Custom-made chisels....
Medicine Products: