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Published on 29 September 2009

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Novartis bronchodilator QAB149 recommended for approval in EU

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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 recognised as an important once-daily COPD treatment with a rapid onset of action,” said Trevor Mundel, 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 and provided clinically relevant improvement in symptoms of breathlessness 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, compared to tiotropium. Relief medication is used to treat acute episodes of severe breathlessness.

COPD is a progressive, life-threatening respiratory disease that affects 210 million people worldwide, and up to 82 million in Europe. Commonly caused by cigarette smoke and other harmful fumes, COPD is characterised 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 incurable, COPD is manageable, and improving airflow with the use of long-acting bronchodilators is central to symptomatic relief.

Data on all evaluated doses of QAB149 show a good overall safety and tolerability profile. 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.

Novartis



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