Novartis announced results from phase-III trials showing QAB149 (indacaterol), an investigational once-daily bronchodilator for chronic obstructive pulmonary disease (COPD), significantly improves lung function and provides a significant reduction in breathlessness compared to tiotropium, a current treatment option. The data were presented this week at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, and build on those presented at the American Thoracic Society (ATS) Annual Meeting earlier this year.
"QAB149 has the potential to be recognized as the best bronchodilator for COPD by providing patients with significantly greater lung function improvement and reductions in breathlessness compared to other bronchodilators," said Trevor Mundel, Global Head of Development at Novartis Pharma AG. "We also plan for QAB149 to form the foundation of a new portfolio of products, designed to improve patients' respiratory health."
At 12 weeks of treatment, QAB149 150 µg and 300 µg improved trough FEV1[§], a key measure of lung function, by 50 ml and 40 ml respectively over tiotropium 18 µg (p<=0.01). New data show at week 26, that patients on QAB149 300 µg continued to show greater improvement in trough FEV1 than tiotropium (p<0.05).
Further new data shows that a higher proportion of patients treated with QAB149 achieved a significant clinically relevant improvement in their symptoms of breathlessness compared to tiotropium. Patients on QAB149 also had a highly significant greater than 20 per cent increase in days during which no 'relief' medication, therapies used to treat acute episodes of severe breathlessness, was required compared to patients treated with tiotropium.
If approved, QAB149 would become the first once-daily bronchodilator to combine clinically relevant 24-hour bronchodilation with onset of action within five minutes. QAB149 is currently undergoing regulatory review in the European Union, the United States and other countries around the world for the treatment of COPD.
"As most COPD patients want to remain active, we need new therapy options that alleviate some of the lifestyle compromises patients are forced to make due to their COPD," said professor Ronald Dahl, University Hospital of Aarhus, Denmark. "These indacaterol data in effect mean that the improvements in lung function are accompanied by important quality-of-life improvements that our patients need."
Data presented on all evaluated doses of QAB149 highlights a good overall safety and tolerability profile. The most common adverse drug reactions were nasopharyngitis, cough, upper respiratory tract infection, and headache. These were mild or moderate in the vast majority of cases and became less frequent if treatment was continued.