On July 5, 2011, Indacaterol was approved by the FDA for the treatment of chronic obstructive pulmonary disease, or COPD. Novartis announced that the brand name for this device would be the Arcapta Neohaler, and the specific approval for this once daily medication is as a long-acting beta2-adrenergic agonist for the maintenance treatment of airflow obstruction. Most commonly seen in patients over age 60, COPD affects over 32 million persons in the United States, and is the fourth leading cause of death in the United States. Patients typically have a triad of symptoms including chronic bronchitis, emphysema, and asthma. It is important to note that Indacaterol is not indicated for the treatment of acute asthma or acute deteriorations of COPD.
The recommended dosage of Indacaterol is one 75 mcg capsule per day, administered via the Neohaler. As the first drug in its class to be approved for once-daily use in patients with COPD, Indacaterol is unique as an easy to use treatment. In fact, researchers have revealed that a very low drop-out rate has been consistently observed in the Indacaterol arm of most comparative clinical trials. This data suggests a good safety and tolerability profile of this inhaled medication. In addition, The Global Initiative for Asthma guidelines recognizes the role of long-acting β2-agonists (LABAs), like Indacaterol, for the optimal treatment of moderate-to-severe persistent asthma. Clinical studies with Indacaterol showed a sustained improvement in lung function and improvements were seen at 5-minutes after the first dose in patients. The clinical trial program supporting Novartis’s US submission evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks, and at doses of 75 mcg each.
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