Novartis Says Data From Ultibro Breezhaler Studies For COPD Shows Improvement

Novartis International AG, of Swiss drug maker Novartis AG (NVS), announced Sunday that new analyses of data for once-daily Ultibro Breezhaler (QVA149) showed significant improvements in lung function, shortness of breath and health-related quality of life for chronic obstructive pulmonary disease or COPD patients.

COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients' function and quality of life. The disease, which affects an estimated 210 million people, is projected to be the third leading cause of death by 2020.

The company noted that new analyses in the IGNITE clinical trial program showed that QVA149 provided superior, rapid and sustained improvements in lung function and significantly reduced shortness of breath versus comparator therapies.

BLAZE study also demonstrated significant improvements in shortness of breath with QVA149 compared to tiotropium 18 mcg in patients with moderate-to-severe COPD.

The company added that SPARK study showed similar rates of reduction in exacerbations with once-daily Seebri Breezhaler (glycopyrronium bromide) and open-label tiotropium 18 mcg in patients with severe-to-very severe COPD.

These data were part of 39 respiratory abstracts presented at the European Respiratory Society or ERS Annual Congress in Barcelona, Spain.

Novartis noted that investigational QVA149, which is currently being assessed in a clinical trial program involving over 10,000 patients, is a Fixed-Dose Combination or FDC of two bronchodilators, Onbrez Breezhaler (indacaterol maleate), a long-acting beta2-adrenergic agonist and Seebri Breezhaler (glycopyrronium bromide), a long-acting muscarinic antagonist. Both are currently used by healthcare professionals as individual therapies to treat COPD.

In July, QVA149 received a positive opinion for approval from the European Medicine Agency's r EMA Committee for the Human use of Medicinal Products as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

Novartis closed Friday's trading at 71.10 Swiss francs, up 0.35 francs or 0.49 percent.

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