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

n people in the US are affected, while another estimated 12 million people are believed to have the disease but remain undiagnosed. COPD ranks as the third leading cause of death in the US and is a major cause of serious long-term disability. Arcapta Neohaler has not been shown to impact mortality or long-term disability caused by COPD.

According to 2011 GOLD Guidelines, bronchodilators are central to COPD management. Bronchodilators have different mechanisms of action and long-acting beta2-agonists (LABA) are among the classes of bronchodilators.

"The COPD Foundation is dedicated to providing information and support individuals with COPD," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "The availability of this new, once-daily LABA is good news for COPD patients looking for new treatment options and for the millions of Americans that are living with this serious disease."

Once-daily Arcapta Neohaler also reduced the need for patients to use short-acting beta2-agonists (albuterol) as rescue therapy, measured as a secondary endpoint. Additionally, Arcapta Neohaler is the only COPD treatment approved with demonstrated improvements in health-related quality of life, as measured by the St George's Respiratory Questionnaire (SGRQ). The SGRQ is a disease-specific, patient-reported instrument that measures health-related quality of life for symptoms, activities and impact of daily life.

The safety and tolerability of Arcapta Neohaler was assessed in a clinical program of more than 5,400 COPD patients, with more than 2,500 who received Arcapta Neohaler for at least 12 weeks at doses of 75 mcg or higher. Adverse reactions were reported by 48% of patients treated with any dose of Arcapta Neohaler compared with 43% of patients treated with placebo. The most common serious adverse reactions were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across t
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SOURCE Novartis Pharmaceuticals Corporation
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