Navigation Links
Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD
Date:6/30/2011

TOKYO, June 30, 2011 /PRNewswire/ --

  • GLOW2 Study Shows NVA237 Provides Superior24-hour Bronchodilation to Placebo (p<0.001) with Comparable Efficacy to Open-Label Tiotropium at 12 Weeks
  • NVA237 Shown to be Well-Tolerated in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
  • Phase III data Support First Regulatory Submission by Novartis for NVA237 by end of 2011


 

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), announces that results reported today by Novartis from the pivotal Phase III GLOW2 clinical trial show that once-daily NVA237 (glycopyrronium bromide) 50 mcg significantly improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) relative to placebo (p<0.001), with similar efficacy to open-label tiotropium.

Further efficacy and safety results from GLOW2 will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval to be filed before the end of 2011.

Mr Shinichi Tamura, CEO of Sosei, said: "GLOW2 is the second NVA237 Phase III study to meet its primary end point and further endorses the benefit of NVA237 in COPD patients.  We look forward to Novartis filing the product in 2011, followed by the filing of QVA149, the fixed-dose combination of NVA237 and indacaterol, expected to occur in 2012 ."

In an exploratory arm of the study, NVA237 was compared with open-label tiotropium (Spiriva® HandiHaler[® Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.]) 18 mcg, another once-daily long-acting muscarinic antagonist (LAMA) indicated for the treatment of COPD. Results show that NVA237 produced similar improvements in lung function to tiotropium.

The study met its
'/>"/>

SOURCE Sosei Group Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. DNA Medicine Institute Awarded Two Phase III SBIR NASA Contracts for Its rHEALTH Sensor
2. Phase I of the Swedish/Issaquah Medical Center Campus to Open in July
3. The Lancet Publishes Data from Protege, MacroGenics Phase 3 Clinical Study of Teplizumab in Type 1 Diabetes Patients
4. Morphotek®, Inc. Announces Initiation of Farletuzumab Phase II Study in First-Line Treatment of Non-Small Cell Lung Cancer
5. Palatin Technologies, Inc. Initiates Enrollment in Phase 2b Trial With Bremelanotide in Women With Female Sexual Dysfunction
6. Cardium Announces Plans to Acquire Transdel Pharmaceuticals Phase 3 Topical Analgesic and Cosmeceutical Business Assets
7. Glycotex, Inc. Releases Final Phase II Clinical Trials Results in the Clinicaltrials.gov Database and Announces the Results of the Mechanism of Action Study for its Product Candidate GLYC-101
8. Ampio Pharmaceuticals, Inc. Releases Results From Phase III Clinical Trial of Zertane™ for the Treatment of Premature Ejaculation (PE), the Most Prevalent Form of Male Sexual Dysfunction
9. Lexicon Presents LX4211 Mechanism of Action Data at American Diabetes Association Meeting and Announces Commencement of Phase 2b Clinical Trial in Type 2 Diabetes
10. Once-Monthly Exenatide Improved Glucose Control in Patients with Type 2 Diabetes: Phase 2 Study Results Presented at ADA 2011
11. New Phase 2 Data Published in New England Journal of Medicine Show Bardoxolone Methyl Sustained Improvement in Measure of Kidney Function (eGFR) Over 52 Weeks in Patients With Moderate to Severe Chronic Kidney Disease and Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014  Diplomat Pharmacy, Inc. (NYSE: DPLO ... to announce Jennifer Hagerman , Pharm.D., AE-C, senior ... office as the president of the Michigan Pharmacists Association ... take place Feb. 28, 2015, at the MPA Annual ... Renaissance Center in Detroit, Michigan . ...
(Date:12/24/2014)... LONDON , December 24, 2014 /PRNewswire/ ... expected to grow at an average rate of 8.1%. ... and volume. Hip, knee and spine surgeries are the ... emerging economies they have a lower penetration. Increased number ... use of composites. Non-metallic orthopedic devices have gained popularity ...
(Date:12/24/2014)... PHILADELPHIA , Dec. 23, 2014 ... a medical device company focused on skin permeation, ... that Scott W. Hollander has been ... Mr. Hollander has more than 20 years of ... equipment industries, and most recently served as Vice ...
Breaking Medicine Technology:Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 2Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 3Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 2Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 3
(Date:12/25/2014)... 2014 Thousands of transvaginal mesh lawsuits ... a number of multidistrict litigations currently underway in U.S. ... LLP reports. According to an Order issued on December ... Joint Status Conference in all of the proceedings on ... directed to submit a proposed agenda to the Court ...
(Date:12/25/2014)... 2014 Plugin creators from Pixel Film ... fully customizable business presentation tool made specifically for ... 5k business tool, users can now display their stats ... Pixel Film Studios. “ProFire 5k gives users a multiple ... professionalism to a presentation” , Pixel Film Studios takes ...
(Date:12/25/2014)... Each year trauma accounts for approximately 42 ... across the nation (according to the Centers for ... Hospital Ambulatory Medical Care Survey collected data from ... They estimated that there were between 3.5 and 4.4 ... diagnosis of broken bone or fracture. , When ...
(Date:12/24/2014)... AlignLife of Wauwatosa loves helping those ... During the holiday season, AlignLife looks forward to their annual ... Dr. Sara Mahalko-Leonhardt, owner of AlignLife. "It brings our patients ... we are able to give kids toys for Christmas who ... the generosity of our patients." , The 70 toys were ...
(Date:12/24/2014)... 2014 Epigenetics finds applications in a ... oncology, drug discovery, developmental biology, and research for metabolic ... of the most widely used techniques for the discovery ... prevalence of cancer is rapidly growing worldwide. In 2012, ... cancer deaths, and 32.6 million people living with cancer ...
Breaking Medicine News(10 mins):Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 4Health News:Announcing a new ProFire 5k plugin from Pixel Film Studios for Final Cut Pro X Professionals 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 3Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 4Health News:AlignLife of Wauwatosa Brings Joy to Less Fortunate Families 2Health News:Global Epigenetics Market Was Valued at $413.24 Million in 2014 - New Research Report by MarketsandMarkets 2Health News:Global Epigenetics Market Was Valued at $413.24 Million in 2014 - New Research Report by MarketsandMarkets 3
... Reporter , WEDNESDAY, Jan. 12 (HealthDay News) -- The next time ... What really matters, new research suggests, is whether your language ... you ask? Well, it,s kind of like chemistry -- it,s there ... focused on was the use of such words as personal pronouns ...
... to traumatic situations demonstrate a more persistent memory of ... with an aversive stimulus - and lack the ability ... that of people who suffer from Post-Traumatic Stress Disorder ... to highly traumatic situations, such as a violent attack, ...
... are fairly common disorders that affect a large proportion ... Clinical Neurophysiology at the Center for Healthy Ageing at ... is head of the Danish Centre for Sleep Medicine, ... country. "Previous studies show that these disorders ...
... worm acts as a ,disguise, for the parasite, resulting in ... The bacteria protect the worm from the body,s natural ... immune system responds appropriately, releasing cells, called eosinophils, that kill ... parasite, but the long treatment regime means that it has ...
... WEDNESDAY, Jan. 12 (HealthDay News) -- Even though they can,t ... spoken words and use the same brain structures as adults ... findings challenge the widely held belief that infants might use ... that this ability begins primitively and evolves into the process ...
... JACKSONVILLE, Fla. A study by researchers at Mayo Clinic,s ... a new twist to the body of evidence suggesting human ... hormone receptors in laboratory mice, neuroscientists identified a new molecular player ... the Jan. 11 online issue of PLoS Biology ...
Cached Medicine News:Health News:Matching Language, True Love? 2Health News:Matching Language, True Love? 3Health News:Drug reduces the increase in fear caused by previous traumatic experiences in mice 2Health News:Sleep-disordered breathing comes at a heavy cost 2Health News:Study sheds new light on river blindness parasite 2Health News:Infants Process Words Much Like Adults, Study Finds 2Health News:Feast or famine: Researchers identify leptin receptor's sidekick as a target for appetite regulation 2
... Electric Micro Sagittal Saw, ... 6 deg. arc. Head rotates ... any angle, and our unique ... slippage. Can also be purchased ...
... The Brasseler USA™ Battery ... quickly and efficiently determine ... STR-2000, STR-3000 Extended Run, ... Driver™, Battery Packs contain ...
... Brasseler USA™ 2002 Battery Charger is manufactured to ... 2002 Battery Charger can charge up to four ... The 2002 Charger is designed to operate on ... is a malfunction in the operation of the ...
... contain rechargeable nickel cadmium battery cells. Heat ... battery life. Strict adherence to recommended autoclave ... recommendations will shorten battery life. Warning: Battery ... of the Battery Packs to autoclave conditions ...
Medicine Products: