Novartis announced today that the US Food and Drug Administration (FDA) has extended the regulatory review period for QAB149 (indacaterol) for the 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 FDA asked for a three-month extension in order to complete its review of the new drug application (NDA) for QAB149 by July 2011. In its notification, the FDA said it needed more time to examine the data submitted by Novartis in support of the application. The agency did not request additional data.

“This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program resulting in a large amount of data to be reviewed,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “COPD is a life-threatening lung disease and a major cause of serious long-term disability[1]. We remain committed to bringing new therapies to patients who suffer from this condition.”

Last month the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) endorsed the safety of both the 75 and 150 mcg doses and voted in favor of approving QAB149 75 mcg in the US, after Novartis presented data showing that QAB149 significantly improved lung function compared to placebo, with improvements seen five minutes after the first dose and lasting for 24 hours[2].

The efficacy of Arcapta Neohaler at 75 and 150 mcg was demonstrated in an extensive clinical trial program in a total of 1,282 COPD patients in five key Phase III trials lasting 12-26 weeks[2].

QAB149 is already approved at 150 and 300 mcg once-daily doses in more than 50 countries worldwide under the brand-name Onbrez^® Breezhaler^® for the maintenance bronchodilator treatment of airflow obstruction in COPD patients[3]. Incremental efficacy benefits have been observed with indacaterol in escalating doses from 75 mcg up to 300 mcg, with higher doses showing increasing benefit for patients

Source: Novartis release