Novartis recently announced encouraging positive results on two of its pivotal Phase III clinical trial programs, the EXPEDITION program to assess the efficacy of QVA149 (indacaterol/glycopyrronium bromide) and the GEM program to evaluate NVA237 (glycopyrronium bromide) in patients suffering with moderate to severe chronic obstructive pulmonary disease (COPD). Both clinical trial programs met their established primary and secondary endpoints. Data on both trials was presented for the first time at The American Thoracic Science (ATS) 2015 International Conference held in Denver, May 15 to 20.
COPD is one of the most common lung diseases and a major cause of morbidity and mortality worldwide, being the third leading cause of death in the United States. It is a progressive disease in which individuals develop serious problems in breathing with obstruction of the airways, shortness of breath (dyspnea), cough and acute exacerbations. It is estimated that 210 million people suffer from COPD worldwide, including almost 27 million individuals in the United States. Smoking is considered to be the leading cause of COPD.
QVA149 is a bronchodilator currently being evaluated as a twice daily dose (indacaterol 27.5 mcg / glycopyrronium bromide 12.5 mcg) in multi-center, randomized, double-blind studies to assess its efficacy, safety and tolerability in COPD patients. It has been analyzed in comparison to monotherapy with its individual components and to once-daily indacaterol (75 mcg) bronchodilator in terms of lung function and adverse events. Through these trials, QVA149 was found to improve lung function, breathlessness and overall quality of life in COPD patients when compared to placebo or its individual components.
“These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life,” said the Global Head of Development, Novartis Pharmaceuticals Vasant Narasimhan in a news release. “With millions of people in the US and around the world struggling to breathe due to COPD, Novartis is committed to advancing QVA149 and other new medicines to address this important unmet need”.
NVA237 is also a bronchodilator, administered twice-daily (glycopyrronium bromide 12.5 mcg), which has shown in multi-center, randomized, double-blind GEM trials to be able to significantly improve lung function, COPD symptoms and overall quality of life in moderate-to-severe COPD patients in comparison to a placebo control.
As a large proportion of COPD patients remain symptomatic despite receiving medical treatment, there is an urgent need for new therapies against the disease. Novartis is currently conducting U.S. regulatory submissions for QVA149 and NVA237 as effective COPD therapies.