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:8/27/2014)... Research and Markets  has announced ... (Biodegradable Polymer, Food & Beverage, Personal Care & ... report to their offering. Lactic ... asymmetrical carbon atom. The main applications of lactic ... beverage, personal care product, and pharmaceutical industries. ...
(Date:8/27/2014)... , Aug. 27, 2014 Guggenheim Securities, the ... today announced the hiring of veteran equity analyst Charles ... analyst. Mr. Butler will focus on the biotech/biopharma sector. ... a wealth of experience and a broad network of ... Senior Managing Director and Head of Equities at Guggenheim ...
(Date:8/27/2014)... , Aug. 27, 2014 Research ... "Global Stable Isotope Ratio Mass Spectrometer Industry Report 2014" ... Global Stable Isotope Ratio Mass Spectrometer Industry Report 2014 ... state of the global isotope ratio mass spectrometer industry. ... the industry including definitions, classifications, applications and industry chain ...
(Date:8/27/2014)... (PRWEB) August 27, 2014 BIOEQUA, an ... through the use of a handheld spray, has made ... United States. , The brand began with an ... researchers were surprised to learn that the application of ... extremely small and delivered directly to skin's basal layer. ...
Breaking Biology Technology:Global Lactic Acid (Biodegradable Polymer, Food & Beverage, Personal Care & Pharmaceutical) Market - Trends & Forecasts to 2019 2Guggenheim Securities Hires Analyst Charles "Tony" Butler to Expand Healthcare Coverage 2Global Stable Isotope Ratio Mass Spectrometer Industry Report 2014 2BIOEQUA'S EQUA ESSENTIAL Product Line Redefines Skin Care & Now Available in America 2
... Isolation Kit , Catalog #732-6370 , ... Cell Lysis , 1. Vigorously add ... (or other tube rated for high speed) containing 500 l body fluid , ... whole blood). , 2. Vortex for 5 sec to mix thoroughly. , ...
... , Patrick M. Gaffney, Elizabeth A. Orbacz, and Ziniu Yu, ... University of Delaware, Lewes, Delaware., , ... DNA polymorphisms are useful tools for ecological and evolutionary ... with applications ranging from , species identification to ...
... Amutan and David Batey, Ph.D., , ... Real-time quantification was performed for lambda and ... DyNAzyme II DNA polymerase*,was used for amplification, and SYBR Green I fluorescent dye ... was tested for ranges,of 100 to 1x10 8 initial copies of lambda ...
Cached Biology Technology:Total RNA Isolation From 500 l Body Fluid 2Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 2Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 3Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 4Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 5Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 6Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 7Using the DCode System to Identify DNA Sequence Variation for Studies of Population Structure in Marine Organisms 8Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 2Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 3Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 4Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 5Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 6Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 7Real-Time Quantification of Genomic DNA Using DyNAzyme II DNA Polymerase and SYBR Green I Dye 8
(Date:8/27/2014)... PITTSBURGHLearning a new skill is easier when it is ... a trained pianist might learn a new melody more ... , Neural engineers from the Center for the Neural ... of Pittsburgh and Carnegie Mellon Universityhave discovered a fundamental ... happens. Published as the cover story in the Aug. ...
(Date:8/27/2014)... greatest risk to Europe based upon a proxy for ... using a ,big data, approach to scientific research. , ... Global Health ranked the top 100 pathogens affecting humans ... system which, they believe, will help governments across the ... infectious diseases, including as a result of climate change, ...
(Date:8/27/2014)... that exists as five strains, none of which have ... the Sudan ebolavirus (SUDV). Although not the strain currently ... as recently as 2012. In a new study appearing ... now report a possible therapy that could someday help ... Sidhu, Jonathan Lai and colleagues explain that about 50-90 ...
Breaking Biology News(10 mins):Pitt and Carnegie Mellon engineers discover why learning can be difficult 2Pitt and Carnegie Mellon engineers discover why learning can be difficult 3Big data approach identifies Europe's most dangerous human and domestic animal pathogens 2Potential therapy for the Sudan strain of Ebola could help contain some future outbreaks 2
... of Princeton biologists and engineers has dramatically improved the speed ... influences almost every aspect of how cells and tissues function. ... cells, cancer and other problems of fundamental importance to biology ... look at a special class of proteins called histones, which ...
... National Institute of Environmental Health Sciences (NIEHS), part of ... in understanding the potential health, safety and environmental issues ... everyday products such as sunscreens, cosmetics and electronics. The ... period, through the American Recovery and Reinvestment Act, to ...
... saliva to tell whether those stiff joints, memory lapses, and ... for disease, scientists are describing how the protein content of ... to a simple, noninvasive test for better diagnosing and treating ... in ACS, Journal of Proteome Research , a monthly ...
Cached Biology News:Beyond genomics, biologists and engineers decode the next frontier 2Beyond genomics, biologists and engineers decode the next frontier 3NIEHS awards Recovery Act funds to focus more research on health and safety of nanomaterials 2NIEHS awards Recovery Act funds to focus more research on health and safety of nanomaterials 3NIEHS awards Recovery Act funds to focus more research on health and safety of nanomaterials 4
... interface. All the functionality of the micro1401 ... memory and more available channels of waveform ... an option for programmable front-end gain. Can ... 48 waveform inputs and from 4 to ...
... reagent is used to inhibit ... fluorescence microscopy. The unique formulation ... wide variety of fixed specimens ... rhodamine, sulforhodamine 101, coumarin, DAPI, ...
Anti-Conjugated Quinaldic Acid...
... and 96 well plates. microCLEAN is an extremely ... half spin DNA cleanup reagent. It can be ... of double stranded DNA, efficiently removing reaction buffers, ... unlabelled). It is therefore ideally suited to clean ...
Biology Products: