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Arcapta Neohaler Approved by FDA for COPD


Arcapta Neohaler (indacaterol inhalation powder) has been approved by the U.S. Food and Drug Administration for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

The term COPD refers to a group of diseases that cause airflow blockage and breathing-related problems, making breathing difficult. It includes emphysema, chronic bronchitis, and in some cases asthma. Symptoms can include breathlessness, chronic cough and excessive phlegm.

Cigarette smoking is the leading cause of COPD in the United States, but asthma, exposure to air pollutants in the home and workplace, genetic factors, and respiratory infections also play a role.

According to the Centers for Disease Control and Prevention, COPD is the fourth leading cause of death in the United States. In 2005, COPD caused an estimated 126,005 U.S. deaths in people older than 25 years. This was an 8% increase from 116,494 in the year 2000. For women, the number of deaths related to COPD in 2005 was 65,193, while for men it was 60,812.

The CDC reports that in the past year 9.9 million adults in the United States were diagnosed with chronic bronchitis and 4.9 million with emphysema.

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Arcapta Neohaler is a new molecular entity in the beta2-adrenergic agonist class that helps muscles around the airways of the lungs stay relaxed to prevent symptoms of COPD, such as wheezing and breathlessness. Arcapta Neohaler is not intended to treat asthma or sudden, severe symptoms of COPD.

"The approval of new long-term drugs for COPD that relieve breathing difficulty by opening airways provides another treatment option for the millions of people,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy of Arcapta Neohaler was demonstrated in six confirmatory clinical trials that included 5,474 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years and exhibited moderate-to-severe decreases in lung function.

Arcapta Neohaler will carry a boxed warning that long-acting beta2 adrenergic agonists (LABA) increase the risk of asthma-related death. All LABA, including Arcapta Neohaler, should not be used in patients with asthma, unless used with a long-term asthma control medication.

The FDA approved Arcapta Neohaler with a medication guide that includes instructions for use and information about the potential risks of taking the drug. The most common side effects reported by those using Arcapta Neohaler include runny nose, cough, sore throat, headache and nausea.

Arcapta Neohaler is marketed by Novartis Pharmaceuticals Corp. of East Hanover, N.J.

Food and Drug Administration
Centers for Disease Control and Prevention