Product Details
QVA149 is an inhaled fixed dose combination product for the treatment of COPD, an irreversible and chronic obstruction of the airways. The product combines NVA237, the long acting anti-muscarinic antagonist (LAMA) licensed to Novartis by Sosei in 2005, together with Novartis’ long acting beta agonist (LABA), indacaterol.
Both NVA237 and indacaterol are once-daily bronchodilators but act on different receptors in the lung thereby offering the potential in combination to provide additional patient benefit.
At the European Respiratory Society held in Vienna in September 2009, Novartis announced positive results of the two Phase II studies. The efficacy and safety study demonstrated the QVA149 showed significant improvements in bronchodilation at 24 hours compared with placebo and indacaterol and was well tolerated, while the safety and tolerability study demonstrated that QVA149 had no significant effect on change in 24 hour mean heart rate from baseline to Day 14 and was well tolerated with overall adverse event rates similar to placebo.
In May 2010, Novartis initiated two 52 weeks Phase III studies. The first will assess the superiority of QVA149 over NVA237 in the rate of exacerbations in 1,998 patients with severe to very severe COPD, together with safety and tolerability. The second trial will assess the long term safety and tolerability of QVA149 in 339 patients with moderate to severe COPD.
In addition, Novartis have reported that they expect to file an NDA submission for QVA149 in 2012.
About COPD
COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. COPD is currently the fourth most common cause of death in the USA and by 2030 is predicted to become the third most common cause of death and the fourth most important disability causing illness. Around three-quarters of patients with advanced COPD are unable to perform normal everyday activities.
The airway obstruction in COPD is largely fixed but is partially reversible by bronchodilator (or other) therapy. In particular, inhaled anti-muscarinic drugs such as ipratropium bromide (Atrovent®) and tiotropium bromide (Spiriva®) have been shown to be beneficial in treating the symptoms of COPD.
Market Overview
COPD is a large and fast expanding market which is estimated to be worth around $6 billion (2007) and is expected to double by 2011 as a result of better recognition of the disease and improved treatment options. In particular recent growth has been driven by Spiriva® which recorded sales of $3.34 billion in 2009.
