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FDA NEWS RELEASE

For Immediate Release: July 1, 2011
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) 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.

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, and is the fourth leading cause of death in the United States, according to the Centers for Disease Control and Prevention.

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 carries 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.

For more information:

National Heart, Lung, and Blood Institute: Chronic Obstructive Pulmonary Disease

Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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