Initial results from three pivotal phase III trials show the Novartis investigational bronchodilator QAB149 (indacaterol) could deliver clinically relevant lung function improvements, within five minutes of the first dose, lasting for 24 hours in patients with chronic obstructive pulmonary disease (COPD).
The data presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego show that QAB149, a long-acting beta2-agonist (LABA), significantly improved lung function from the first day of therapy to up to one year of treatment. The data also reveal that all evaluated doses of QAB149 were well-tolerated and had a good overall safety profile.
All doses of once-daily QAB149 met the primary efficacy endpoint of significant improvement in FEV1 (forced expiratory volume in one second) versus placebo at twelve weeks. This improvement was seen as early as five minutes post-dose and at every subsequent time point measured in each study. In INVOLVE QAB149 (300µg and 600µg) also showed significant improvements over formoterol 12µg in trough FEV1 difference versus placebo at three months (170ml and 170ml vs. 70ml; p<0.001), and at one year (160ml and 150ml vs. 50ml; p<0.001).
In addition to data presented at ATS, Novartis released data today showing that at 12 weeks, QAB149 (150µg and 300µg) achieved additional improvements of 50ml and 40ml, respectively, versus open-label tiotropium 18µg, in trough FEV1 or 24-hour post-dose forced expiratory volume in one second. Further presentation of study results is planned for later this year.
"Bronchodilator treatment is the first-line approach for the symptomatic management of patients with COPD, and long-acting bronchodilators have a number of advantages," said professor Stephen I Rennard, Pulmonary and Critical Care Medicine, University of Nebraska Medical Center. "The indacaterol data presented at ATS show that bronchodilation on a once-daily basis may be an important addition to the current therapeutic armamentarium in COPD."
COPD is a progressive, life-threatening respiratory disease that affects 210 million people worldwide. Commonly caused by cigarette smoke and other harmful fumes, COPD is characterized by a persistent obstruction of airflow in the lungs, resulting in breathlessness. According to the World Health Organization, COPD is currently projected to become the third leading cause of death worldwide by 2030. Bronchodilators are a group of drugs that widen the airways in the lungs. While COPD is incurable, improving airflow with the use of long-acting bronchodilators is central to symptomatic management.
"Novartis is committed to developing a range of therapies for patients with respiratory diseases such as COPD," said Trevor Mundel, global head of Development at Novartis Pharma AG. "QAB149 could become the foundation of a portfolio of medicines that aims to improve peoples' respiratory health."
QAB149 is currently undergoing regulatory review in the European Union and the United States. If approved, QAB149 could become the foundation of a Novartis portfolio of products, including fixed-dose combinations, designed to address unmet needs in respiratory care.