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Novartis launches Arcapta™ Neohaler™, a novel once-daily bronchodilator for chronic obstructive pulmonary disease
Date:3/19/2012

EAST HANOVER, N.J., March 19, 2012 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced that once-daily Arcapta™ Neohaler™ (indacaterol inhalation powder) 75 mcg is now available in the US and in pharmacies nationwide.

Arcapta Neohaler is indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta Neohaler is not indicated to treat asthma. It is also not indicated to treat acute deteriorations of COPD and should not be used as a rescue medication for acute symptoms.

Arcapta Neohaler is the only once-daily, 24-hour long-acting beta2-agonist (LABA) approved in the US for maintenance treatment of airflow obstruction in patients with COPD. Arcapta Neohaler is an inhaled, steroid-free COPD treatment.

Arcapta Neohaler 75 mcg was studied in a total of 641 COPD patients in two key Phase III trials lasting 12 weeks. The primary endpoint results at week 12 showed that Arcapta Neohaler significantly improved lung function (FEV1) at 24 hours compared to placebo. As a secondary endpoint, lung function (FEV1) improvements were seen at five minutes after the first dose compared to placebo, and improvements observed at week 4 were consistently maintained over the course of 12 weeks in both trials.

"Arcapta Neohaler represents an important new treatment option for the 14 million Americans living with COPD," said Andre Wyss, President, Novartis Pharmaceuticals Corporation. "The launch of Arcapta Neohaler is a significant milestone as we continue to establish a strong respiratory presence in the US market."

COPD is a common, preventable and treatable disease characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways of the lungs to noxious particles or gases. More than 14 millio
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SOURCE Novartis Pharmaceuticals Corporation
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