Zurich: Swiss drugmaker Novartis AG said the U.S. Food and Drug Administration had requested more information on dosing proposed for its drug for "smoker`s lung," or chronic obstructive pulmonary disease.
Novartis said in a statement on Monday it would work with the FDA to review already submitted data for the drug, QAB149, as well as recently available data to determine what, if any, further clinical trials would be required.
"Our confidence in the benefit/risk profile of QAB149 is based on results of Phase III trials which showed QAB149 significantly improved lung function," said Trevor Mundel, Global Head of Development at Novartis Pharma AG.
QAB149, or indacaterol, is the first once-daily bronchodilator treatment for adult patients with COPD.
The European Medicines Agency recommended approval of the drug last month in a boost for Novartis` ambitions in respiratory medicine, a field currently dominated by GlaxoSmithKline, AstraZeneca and Pfizer.
The European Commission generally follows the recommendations of the London-based medicines agency and delivers its final decision within three months.
Novartis will initially sell QAB149 as a monotherapy. But industry analysts believe unlocking the medicine`s full sales potential -- which some have put at $3-$5 billion a year -- will depend on combining QAB149 with other treatments.
Novartis is studying combinations with NVA237, a new drug it is developing with Vectura, and with Schering-Plough`s inhaled steroid mometasone. Those combinations may not reach the market until around 2013, analysts estimate.
Bureau Report
