FDA delays decision on Novartis’ COPD drug

pharmafile | March 23, 2011 | News story | Sales and Marketing |  COPD, Novartis, Onbrez Breezhaler, QAB149, bronchodilator, chronic obstructive pulmonary disease, indacterol 

The FDA has delayed its licence decision on Novartis’ once-daily COPD treatment QAB149 by three months.

The review process will now conclude in July but, encouragingly for Novartis, the FDA has not requested any additional data on the bronchodilator.

Novartis says the FDA needs more time to complete its review because of the large amount of data involved in the QAB149’s clinical trial programme.

Novartis recently won the backing from an FDA advisory committee for QAB149 (indacterol), which is known and approved as Onbrez Breezhaler in Europe.

Trevor Mundel, global head of development at Novartis Pharma AG 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.

“COPD is a life-threatening lung disease and a major cause of serious long-term disability. We remain committed to bringing new therapies to patients who suffer from this condition.”

QAB149 was originally submitted for US approval in 2008, but a 2009 Complete Response Letter from the FDA knocked it back with a request for more information on its dosing.

If the FDA gives QAB149 the green light the Swiss healthcare firm will market the drug under the brand name Arcapta Neohaler.

It would then compete with Forest Laboratories’ once-daily, first-in-class oral COPD treatment Daliresp, which the FDA approved earlier this month.

Associated with tobacco smoking, COPD affects 210 million people worldwide and is projected to be the third leading cause of death by 2020. It causes obstruction of airflow in the lungs – resulting in debilitating bouts of breathlessness.

Brett Wells