BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.
The FDA asked for a three-month extension in order to complete its review of the new drug application for QAB149 (indacaterol) by July, stating the agency needed more time to review the submitted data. The FDA did not request additional data from the drug maker, Novartis noted.
The drug, which will be available in 75-mcg and 150-mcg strengths, was endorsed by the FDA's Pulmonary-Allergy Drugs Advisory Committee for its safety.
"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, global head of development at Novartis. "COPD is a life-threatening lung disease. We remain committed to bringing new therapies to patients who suffer from this condition."