FDA extends Novartis COPD drug NDA review period

The FDA will complete the review by July 2011, as it needs more time to investigate the data submitted by Novartis in support of QAB149 NDA.

The company’s drug QAB149 has been approved in 50 countries worldwide under the brand-name Onbrez Breezhaler for the maintenance bronchodilator treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD) patients.

Novartis Pharma Global Development head Trevor Mundel said 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.