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, now approved in more than 70 countries, including EU, Japan and the USA.
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. It is expected that the drug will be launched as a first-in-class once –daily LAMA/LABA combination drug in this therapeutic area.
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 mono-therapy, 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 Phase III studies for QVA149. At present six Phase III studies are being undertaken to assess safety, efficacy, tolerability etc. of QVA149 in some 5,500 COPD patients.
Novartis announced that the first launch for QVA149 is planned for 2013.
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. Worldwide, COPD is estimated to affect a total of 210 million people and is projected to become the third leading cause of death by 2020.
Market Overview
COPD is a large and fast expanding market which is estimated to be worth around $9 billion (2008) and is expected to reach $11 billion by 2014 as a result of better recognition of the disease and improved treatment options.
