LTC Bulletin Board - July 2011: Page 2 of 5

July 22, 2011


FDA Approves New Treatment for Pulmonary Disease

On July 1, 2011, the FDA approved Arcapta Neohaler (indacaterol inhalation powder), the first once-daily, long-acting beta2 adrenergic agonist (LABA) approved to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arcapta Neohaler helps muscles around the airways of the lungs stay relaxed to prevent COPD symptoms, such as wheezing and breathlessness. It 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 millions of people,” said Curtis Rosebraugh, MD, MPH, director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, in an FDA statement.

The FDA’s approval of Arcapta Neohaler was based on the safety and efficacy observed with the drug in six confirmatory clinical trials that included a cumulative 5474 COPD patients ≥40 years of age. Those treated had a history of smoking at least one pack a day for 10 years and exhibited moderate-to-severe decreases in lung function.

The most common side effects reported by patients were runny nose, cough, sore throat, headache, and nausea. As with all LABAs, Arcapta Neohaler may increase the risk of asthma-related death and should not be used in patients with asthma, unless used with a long-term asthma control medication.

Novartis is anticipating an early 2012 launch of Arcapta Neohaler in the United States. The drug is already approved as a COPD treatment in more than 60 countries and is currently available in approximately 30. For more information, visit the Arcapta Website (