Navigation Links
FDA Advisory Committee Recommends US Approval of Novartis Once-daily Bronchodilator QAB149 for COPD
Date:3/8/2011

al program supporting US submission evaluated safety in 4,764 patients who received QAB149 for at least 12 weeks at doses of 75 mcg and greater, with results supporting the safety and tolerability profile of QAB149. The most commonly reported adverse events with both the 75 and 150 mcg doses were worsening of COPD, nasopharyngitis, cough, and headache.

"We must intensify our efforts to increase awareness, prevention and detection, and to develop new treatments to help reduce the enormous burden COPD places on patients, their families and our healthcare system," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "Deaths from COPD are increasing much faster than previously projected, which should be a wake-up to all of us."

QAB149 is approved at 150 and 300 mcg once-daily doses in more than 50 countries worldwide under the brand-name Onbrez® Breezhaler®. Altogether, the clinical trial program for QAB149 involved more than 15,000 people of whom 9,243 were given QAB149 at varying doses and assessed for safety.

In the US, Novartis is seeking approval for the use of QAB149 as a once-daily long-term maintenance bronchodilator treatment for airflow obstruction in patients with COPD, including bronchitis and/or emphysema. Novartis is not seeking an indication for asthma. If approved in the US, the proposed brand name will be Arcapta™ Neohaler™.

COPD, a progressive and life-threatening lung disease making it difficult to breathe, affects more than 12 million people in the US, while another 12 million people are estimated to have the disease but are undiagnosed. COPD ranks as the third leading cause of death in the US and is a major cause of serious long-term disability.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "recommends," "recommended," "recommending," "recommendation," "recommendations,"  "commit
'/>"/>

SOURCE Novartis Pharmaceuticals Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Myriant Technologies, Inc. Announces J. Brian Ferguson to Join Advisory Board
2. Sensus Healthcare Announces the Formation of a Medical Advisory Board
3. Max Neeman International Initiates Advisory Committee to Advance and Improve the Conduct of Complex Neurological Trials in India
4. Leading Dental Stem Cell and Regenerative Medicine Researcher Dr. George Huang Joins StemSaves Science Advisory Council
5. Carl A. Miller, PhD, Joins iDiverses Business and Scientific Advisory Board
6. Dr. Russell L. Chapman Joins Aquatic Energy as the Chairman of its Science Advisory Board
7. Chimerix Presents Update on CMX001 Development to the World Health Organization Advisory Committee on Variola Virus Research
8. IGEN Networks Corp continues to build a world class advisory board, with the appointment of three new members
9. IGEN NETWORKS ANNOUNCES THE APPOINTMENT OF TWO NEW MEMBERS TO THE ADVISORY BOARD
10. Regenicin Appoints Renowned New York Dermatologist, Dr. Gervaise Gerstner to Scientific Advisory Board
11. Signal Genetics Announces Establishment of Scientific Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... , Oct. 22, 2014 /PRNewswire/ - iCo Therapeutics ("iCo" ... announced next steps for its Oral Amphotericin B ... its in vitro work involving samples ... now plans to complete pre clinical studies and ... Phase 1A clinical trial, utilizing approximately $700,000 of ...
(Date:10/22/2014)... DUBLIN , Oct. 22, 2014 ... "Organic Electronics Market by Material, by Application, Geography ... report to their offering. Organic electronics, ... a branch of material science which deals with small ... as organic because small molecules and polymers are carbon ...
(Date:10/20/2014)... The report “Pharmacy Automation Systems Market by product ... Table-top Counters) by End-user (Inpatient Pharmacy Automation, Outpatient ... 2019” analyzes and studies the major market drivers, ... and the Rest of the World (RoW). , ... through 300 pages and in-depth TOC on "Pharmacy ...
(Date:10/20/2014)... 2014 Convey Computer , the ... from Iowa State University won first place in the ... Convey HC-2ex, the team’s solution achieved the highest overall ... the second place finisher. , Experts from all segments ... month long challenge, using a variety of design tools, ...
Breaking Biology Technology:iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 2iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 3Global Organic Electronics (Semiconductor, Conductive, Dielectric and Substrate) Market - Analysis and Forecast (2014 - 2020) 2Global Organic Electronics (Semiconductor, Conductive, Dielectric and Substrate) Market - Analysis and Forecast (2014 - 2020) 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 4Team from Iowa State Wins 2014 MemoCODE Design Contest Using Convey HC-2ex 2Team from Iowa State Wins 2014 MemoCODE Design Contest Using Convey HC-2ex 3
... on powerful computational tools and a state-of-the-art scanning ... Wisconsin-Madison and Iowa State University materials science and ... structure in solid metallic materials known as metallic ... Physical Review Letters , the findings fill ...
... May 11, 2012   Synthetic Biologics, Inc. (NYSE Amex: ... and innovative disease-modifying medicines for serious illnesses, announced today ... Board, it has split the roles of Chairman and ... serve as its independent, non-executive Chairman of the Board. ...
... ORLANDO, Fla., May 10, 2012   GeneLink, Inc. ... leading consumer genomics biotech company, reports financial results for the ... Results: , The Company reached an agreement ... Life Sciences, Inc. to Capsalus Corp (OTCBB:WELL.OB, or "Capsalus"). Capsalus ...
Cached Biology Technology:In metallic glasses, researchers find a few new atomic structures 2In metallic glasses, researchers find a few new atomic structures 3Synthetic Biologics Appoints Jeffrey J. Kraws as Independent Chairman 2Synthetic Biologics Appoints Jeffrey J. Kraws as Independent Chairman 3GeneLink Reports 2011 Financial Results 2GeneLink Reports 2011 Financial Results 3
(Date:10/17/2014)... German . Why ... order to reproduce? And why are there two sexes anyway? ... issue of the research journal Molecular Human Reproduction ... from Bielefeld University Bielefeld has compiled this special issue on ... female to copulate with several males in quick succession – ...
(Date:10/16/2014)... have a new synthesis of recent research findings to ... in the two states. , The Ecology and ... Washington: A Synthesis of the Relevant Biophysical Science and ... published by the U.S. Forest Service,s Pacific Northwest Research ... managers for a synthesis of the large body of ...
(Date:10/16/2014)... 2014 NXT-ID, Inc. (NASDAQ: NXTD ... authentication company focused on the growing mobile commerce market ... Wocket™, the Smart Wallet, at the 13 th ... leading global conference on the intersection of technology and ... Anderson , founder and publisher of the Strategic News ...
Breaking Biology News(10 mins):Sperm wars 2New report synthesizes best available science on management of moist mixed-conifer forests 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 3
... racking your brain on a Monday morning to remember where ... those keys, you can thank the hippocampus, a brain region ... that room where your keys were hiding in an unusual ... Biological Studies have helped explain how the brain keeps track ...
... A dysfunction of a certain Calcium channel, the so called ... cause different motor diseases as well as a special type ... Dr. Melanie Mark and Prof. Dr. Stefan Herlitze from the ... of the P/Q-type in the modulatory input neurons of the ...
... compared water quality trends in forested streams across the country ... changes. The study, which draws on decades, worth of ... Rico, underscores the value of long-term data in understanding the ... rivers. It is published in the current issue of the ...
Cached Biology News:The neuroscience of finding your lost keys 2The neuroscience of finding your lost keys 3Dysfunction in cerebellar Calcium channel causes motor disorders and epilepsy 2Study explores long-term water quality trends in near-pristine streams 2
... CultureWell cell culture systems provide an ... for staining and imaging. Each system ... standard optical-quality coverslips in cell culture ... sterile and ready to use. Individual ...
RECOMBINANT EQUINE IL-4 Product Type: Recombinant Protein...
RECOMBINANT EQUINE TNF ALPHA Product Type: Recombinant Protein...
Request Info...
Biology Products: