In July 2011, the Food and Drug Administration (FDA) approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist (LABA), at a dose of 75 μg once daily as a bronchodilator for patients with chronic obstructive pulmonary disease (COPD).1 Since the European Medicines Agency (EMA) had approved indacaterol at doses of 150 μg and 300 μg in 2009,2 one might question why the FDA selected a 75-μg dose.

Historically, LABAs have been developed first for patients with asthma and then the same dose has been applied to patients with COPD. Indacaterol's manufacturer, Novartis, took a different approach: it focused primarily on patients with COPD and proposed two different doses for marketing. Novartis submitted its new drug application (NDA) to the FDA in October 2009, proposing doses of 150 μg and 300 μg once daily. The NDA was not approved, because the data did not show a meaningful difference in efficacy between the proposed doses and a lower dose (75 μg), and there were safety concerns regarding the proposed doses. ...

N Engl J Med. 2011 Dec 15;365(24):2247-9
Authors: Chowdhury BA, Seymour SM, Michele TM, Durmowicz AG, Liu D, Rosebraugh CJ
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