Overview
In July 2011, the Food and Drug Administration (FDA) approved ARCAPTA NEOHALER (indacaterol maleate inhalation powder; marketed by Novartis Pharmaceuticals) as a once-daily bronchodilator for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.[1,2,3]
Indacaterol is an “ultra” long-acting ß2-adrenergic agonist (ultra-LABA) that is distinguished by once-daily dosing due to its long duration of action of >24 hours, compared to twice-daily dosing of other LABAs such salmeterol and formoterol that have a bronchodilator action of ~12 hours. Indacaterol has a fast onset and produces sustained bronchodilation; it relaxes bronchial smooth muscle to reduce the symptoms of COPD, and is well tolerated. In March 2011, after reviewing the data obtained from 6 confirmatory clinical studies, the FDA medical advisory panel voted for the approval of ARCAPTA NEOHALER in the 75 µg dose only, citing lack of evidence of an added benefit and the potential of safety disadvantage with higher doses.[1,2] Indacaterol is intended for the long-term maintenance treatment of COPD. It is not to be used for treatment of asthma or sudden acute and severe symptoms of COPD. Similar to all LABAs, indacaterol carries a boxed warning that it may increase the risk of asthma-related deaths.[1,2,3]
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