New analyses demonstrate Novartis Onbrez® Breezhaler® (indacaterol) significantly reduces COPD patient need for ‘relief’ medication

New analyses of data pooled from the indacaterol Phase III program that led to approval in the EU and some other countries, presented at the American Thoracic Society (ATS) 2010 International Conference in New Orleans today, showed that once-daily indacaterol, when compared to open-label tiotropium (18 µg, once daily), increased the percentage of days for which patients did not require any ‘relief’ medication by up to 13 percent over six months of treatment (p<0.001)₁.

Pooled data from three pivotal clinical trials_2,3,4 analyzed for the first six months of treatment showed that the percentage of days for which patients did not require any ‘relief’ medication – which are short-acting bronchodilators used by COPD patients to treat symptoms such as acute episodes of severe breathlessness – significantly increased for patients treated with once-daily indacaterol 150 μg and 300 μg (22.8% and 25.9% change from baseline, respectively). This increase was significant when compared with open-label tiotropium (18 µg, once daily) (12.7% change from baseline; p<0.001)₁.

Additionally, pooled data from three pivotal clinical trials_2,3,5 analyzed for the first three months of treatment demonstrated indacaterol (150 µg and 300 µg) given once daily delivered clinically relevant* lung function improvements across age groups both <65 and >65 years, when compared to placebo (p<0.001). When compared to formoterol (12 µg, twice daily), both doses of indacaterol offered significantly greater bronchodilation in both age-stratified subgroups (p<0.05)₆.

Data presented also showed that once-daily indacaterol (150 μg and 300 μg) over three months of treatment reduced the rate of patient COPD exacerbations, compared to placebo₇.

“Today’s data builds on the Phase III pivotal data presented last year and adds to the growing body of evidence that indacaterol can have an important role in the clinical management of COPD,” said Donald A. Mahler, MD, Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

Improving the management of COPD and other respiratory diseases is a priority for Novartis. Indacaterol is approved for COPD in the European Economic Area (EEA), Chile, Lebanon and India. Indacaterol is the lead compound in an expected portfolio for treatment of this growing public health issue that affects 210 million people globally8, the majority of whom are under the age of 659, and is projected to become the third leading cause of death worldwide by 202010. Novartis has three additional investigational treatments in its 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.

“Novartis is dedicated to offering effective therapies for patients with respiratory illnesses,” said Steffen Roellinger, Global Head of Development, Respiratory Franchise, Novartis AG. “The results on indacaterol presented at ATS this year further support that commitment to patients with COPD.”

Further study results with indacaterol are expected later this year.

*Defined as >120 mL more than placebo in forced expiratory volume in one second (FEV1), a standard measure of lung function.

www.novartis.com

References

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