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FDA panel backs Novartis COPD drug

An advisory committee has voted to recommend that the US Food and Drug Administration approve Novartis' QAB149 (indacaterol)

An advisory committee has voted to recommend that the US Food and Drug Administration (FDA) approve Novartis' QAB149 (indacaterol) as the first 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 Pulmonary-Allergy Drugs Advisory Committee, acting on a request from the FDA to evaluate the data for lower doses of QAB149, voted 13 to four in favor of recommending approval of a 75mcg dose, but 12 to five against recommending approval of a 150mcg dose.

The committee members deemed the lower dose as effective as the higher one and determined that the data showed that both doses are safe.

The advisory committee made its recommendations after reviewing five phase III clinical trials in which the efficacy of QAB149 at 75 and 150 mcg was studied in a total of 1,282 COPD patients. The data showed that both doses significantly improved lung function compared to placebo, beginning five minutes after the first dose and lasting for 24 hours.

QAB149 was submitted for US regulatory approval in December 2008. In late 2009, the FDA issued a complete response letter declining to approve the drug until Novartis provided additional information on the proposed dosing.

QAB149 is already approved at 150 and 300mcg once-daily doses in more than 50 countries under the brand-name Onbrez Breezhaler.

9th March 2011

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