Novartis has received a positive opinion recommending European Union (EU) approval of QAB149 (indacaterol) for maintenance bronchodilator treatment in adult patients with chronic obstructive pulmonary disease (COPD). When approved, QAB149 and its device, Concept-1, will be known as Onbrez® Breezhaler®[§].

"QAB149 has the potential to be recognized as an important once-daily COPD treatment with a rapid onset of action," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "QAB149 provides COPD patients with greater lung function improvements and reductions in breathlessness compared to other bronchodilators. On approval, our plans are for QAB149 to form the foundation of a new portfolio of potential products designed to improve patients' respiratory health."

The positive opinion for two dose strengths of QAB149, 150 mcg and 300 mcg, has been issued by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months.

QAB149 is currently undergoing regulatory review in the United States, where the regulatory submission was filed in late 2008.

Results from pivotal Phase III trials, presented recently at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, showed QAB149 significantly improved lung function[1] and provided clinically relevant improvement in symptoms of breathlessness[4] compared to tiotropium, a current treatment option. Further data showed QAB149 provided a greater than 20 percent increase in days during which no 'relief' medication was required[5], compared to tiotropium. Relief medication is used to treat acute episodes of severe breathlessness.

COPD is a progressive, life-threatening respiratory disease[10] that affects 210 million people worldwide[6], and up to 82 million in Europe[7],[8]. Commonly caused by cigarette smoke and other harmful fumes, COPD is characterized by a persistent obstruction of airflow in the lungs, resulting in breathlessness[10]. According to the World Health Organization, COPD is currently projected to become the third leading cause of death worldwide by 2030[9]. Bronchodilators are a group of drugs that widen the airways in the lungs. While incurable, COPD is manageable, and improving airflow with the use of long-acting bronchodilators is central to symptomatic relief[11].

Data on all evaluated doses of QAB149 show a good overall safety and tolerability profile[12],[13]. 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 when treatment was continued.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

[1] Fogarty C, Hébert J, Iqbal A et al. QAB149 once-daily provides effective 24-h bronchodilation in COPD patients: a 26-week evaluation vs placebo and tiotropium. Abstract accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.
[2] Dahl R, Kolman P, Jack D et al. Bronchodilator therapy with QAB149 once-daily in COPD: a 52-week comparison with formoterol. Abstract accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.
[3] Balint B, Watz H, Amos C et al. Fast onset of bronchodilation with QAB149 in patients with COPD. Abstract accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.
[4] Mahler DA, Palange P, Iqbal A et al. QAB149 once-daily improves dyspnoea in COPD patients: a 26-week placebo-controlled study with open-label tiotropium comparison. Abstract accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.
[5] Lötvall J, Cosio BG, Iqbal A et al. QAB149 once-daily improves day and night-time symptom control in COPD patients: a 26-week study versus placebo and tiotropium. Abstract and poster accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.
[6] World Health Organization. Factsheet No 315 Chronic obstructive pulmonary disease (COPD). http://www.who.int/mediacentre/factsheets/fs315/en/index.html (accessed 14 September 2009).
[7] Halbert RJ, Isonaka S, George D et al. Interpreting COPD Prevalence Estimates. What Is the True Burden of Disease? Chest 2003;123:1684-1692.
[8] Lanzieri G. Population in Europe 2007: first results. Eurostat. Statistics in Focus 81/2008, Population and social conditions.
[9] World Health Organization. COPD predicted to be third leading cause of death in 2030. http://www.who.int/gard/news_events/World_Health_Statistics_2008/en/index.html (accessed 14 September 2009).
[10] NHBLI. What is COPD? http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html (accessed 14 September 2009).
[11] Global Initiative for Chronic Obstructive Pulmonary Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Lung Disease. Updated 2007.
[12] Worth H, Kleerup E, Iqbal A et al. Safety and tolerability of QAB149 once-daily in COPD patients versus placebo and tiotropium: a 26-week study. Abstract accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.
[13] Chung KF, Kornmann O, Jack D et al. Safety and tolerability of indacaterol over 52 weeks of treatment in COPD. Abstract accepted for presentation at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna, Austria, 12-16 September 2009.

[§] Onbrez® Breezhaler® are the names for indacaterol and its delivery device, Concept1, which are pending approval in the EU.