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Published on 3 December 2009

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Novartis receives approval in the European Union

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Novartis announced today that the European Commission (EC) has approved Onbrez Breezhaler (QAB149 or indacaterol) in both 150 mcg and 300 mcg doses as a new once-daily maintenance bronchodilator treatment

The treatment is for airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

“Onbrez Breezhaler has demonstrated greater improvements in lung function, breathlessness and quality of life compared to current therapies,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division.

“The EC approval of Onbrez Breezhaler means this new and effective therapy will soon be available to people in the EU with COPD and, through better symptom control, will help them to live more active and productive lives despite their condition.”

Onbrez Breezhaler, containing the active ingredient indacaterol maleate, is the first new inhaled compound for the treatment of COPD to be made available for EU patients in seven years.

Additionally, it is the first and only treatment to demonstrate in clinical studies both 24-hour bronchodilation and a rapid onset of action within five minutes of inhalation.

COPD is a progressive, life-threatening respiratory disease that affects 210 million people worldwide, up to 82 million in Europe, the majority of whom are under the age of 65.

COPD impairs lung function resulting in chronic breathlessness. This leads to a profound, negative impact on patients’ ability to work and support families. COPD currently ranks tenth in overall disease burden, ahead of asthma and diabetes.

The EC based its approval of Onbrez Breezhaler on data from over 6,000 patients. This data included pivotal Phase III results showing Onbrez Breezhaler significantly improved lung function and provided clinically relevant improvement in symptoms of breathlessness compared to tiotropium.

Recent data presented at the American College of Chest Physicians (ACCP) Chest Conference showed once-daily Onbrez Breezhaler also achieved significant improvements in lung function compared to twice-daily salmeterol, another current treatment option.

In addition, Onbrez Breezhaler provided better health status* and improved breathlessness compared with salmeterol.

Onbrez Breezhaler has shown good overall safety and tolerability, which is comparable to other current treatments. The most common adverse drug reactions were nasopharyngitis, cough, upper respiratory tract infection, and headache. These were in the vast majority mild or moderate and became less frequent as treatment was continued.

QAB149 was filed with the United States Food and Drug Administration (FDA) in late 2008. In October 2009, Novartis received a Complete Response letter from the US. The FDA requested additional information on the dosing proposed, which Novartis is working to address.

Improving the management of COPD is a priority focus for Novartis and Onbrez Breezhaler is the lead compound in an expected once-daily portfolio for the treatment of this growing public health issue.

Novartis has three additional investigational treatments in its late-stage COPD portfolio, NVA237, QVA149 and QMF149. Novartis is also exploring new pathways in the treatment of COPD as part of an innovative, early-stage pipeline with disease modifying potential.

Novartis



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