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

EAST HANOVER, N.J., March 8, 2011 /PRNewswire/ -- An advisory committee recommended today that the Food and Drug Administration (FDA) approve QAB149 (indacaterol) 75 mcg in the US as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The committee voted 13 to four in favor of recommending approval of the 75 mcg dose. The advisory committee also voted 12 to five against recommending approval of the 150 mcg dose. The 75 mcg dose was seen as effective as the 150 mcg dose and the committee endorsed the safety of both doses.

The recommendation by the Pulmonary-Allergy Drug Advisory Committee (PADAC) followed a request from the FDA to further explore the efficacy and safety of lower doses of QAB149, an investigational medicine in the long-acting beta2-agonist (LABA) class.

The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug for approval, although it is not obliged to follow the committee's recommendations.

"Novartis is committed to addressing the needs of patients with COPD and we are encouraged by the advisory committee's recommendation for approval of QAB149," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "The company is focused on bringing innovative, safe and effective treatment options to patients and physicians, and we will work closely with the FDA as it completes its review of QAB149."

The advisory committee reviewed an extensive program of clinical trials in which the efficacy of QAB149 at 75 and 150 mcg was studied in a total of 1,282 COPD patients in five key Phase III trials lasting 12-26 weeks. Results showed that both doses of QAB149 significantly improved lung function compared to placebo. These improvements were seen five minutes after the first dose and lasted for 24 hours.

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SOURCE Novartis Pharmaceuticals Corporation
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