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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.

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The foregoing release contains forward-looking statements that can be identified by terminology such as "recommends," "recommended," "recommending," "recommendation," "recommendations,"  "commit
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SOURCE Novartis Pharmaceuticals Corporation
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