Arcapta (indacaterol) is the first long-acting beta-2 agonist (LABA) approved for once-daily
use. FDA approved indacaterol in July 2011 for maintenance treatment of airflow
obstruction in patients with chronic obstructive pulmonary disease (COPD).1,2 The
medication received approval in Europe in 2009 at doses of 150 and 300mcg and has demonstrated
safety and efficacy in six clinical trials that included 5,474 patients ages 40 and older with a
clinical diagnosis of COPD.2,3 Indacaterol is not approved for the treatment of asthma
and maintains the same black box warning that LABAs increase the risk of asthma-related
death.2 The approved U.S. treatment dose of indacaterol is 75mcg (contents of one
capsule) inhaled once daily at the same time every day with the Neohaler device with the most common
adverse effects reported during indacaterol use including runny nose, cough, sore throat, headache
COPD is the fourth leading cause of death in the United States according to the
Centers for Disease Control and Prevention.4 While smoking cessation remains a primary
goal in the management of COPD, current guidelines recommend regular treatment with long-acting
inhaled bronchodilators for patients with moderate and severe symptoms, with the addition of inhaled
corticosteroids (ICS) for those patients with severe disease and repeated exacerbations.5
Currently available long-acting inhaled bronchodilators are the long-acting anticholinergic (LAAC)
tiotropium and the LABAs, salmeterol and formoterol.
Indacaterol offers another treatment option for the management of COPD, but it
is of note, that only two of the six confirmatory trials that lead to its approval utilized the
approved dose of 75mcg daily. The remaining trials included doses similar to those approved for use
in Europe including 150, 300, and 600mcg once daily. All six
trials enrolled patients with a clinical diagnosis of COPD, who were 40 years or older, had a
smoking history of at least 10 pack years, had a post-bronchodilator FEV1 less than 80%
and at least 30% of the predicted normal value and a post-bronchodilator ratio of FEV1
over FVC of less than 70%.1 The primary efficacy endpoint was 24-hour post dose trough
FEV1 after 12 weeks of treatment in all six trials with other endpoints including rescue
medication use, symptoms, and health-related quality of life.1 In all trials, indacaterol
demonstrated significantly greater 24-hour post-dose trough FEV1 compared to placebo at
Place in Therapy
Indacaterol offers an alternative treatment option for patients with moderate
to severe symptoms associated with COPD, such as wheezing and breathlessness. The once-daily dosing
of indacaterol is the most obvious advantage to its use over other currently available LABAs, but
this has been an advantage of the once-daily dosed LAAC tiotropium. A trial conducted to assess the
efficacy of indacaterol vs. tiotropium demonstrated that indacaterol dosed at either 150 or 300mcg
daily was found to be at least as effective as tiotropium 18mcg daily in its effect on symptoms and
health status6 Currently, the main limitation to routine use of indacaterol would be the
approved dose of 75mcg daily as this is below the approved dose in Europe and the majority of
clinical trials assessing indacaterol efficacy. The approved dose was based in part on a blinded
meta-analysis comparing indacaterol-treated patients to controls with respect to composite incidence
of COPD-related deaths, hospitalizations, and intubations.7
Indacaterol should be available in early 2012 and based on current evidence may
be a good alternative for patients taking a twice-daily dosed LABA and struggling with compliance.
While indacaterol offers an alternative option to tiotropium, its efficacy at the approved 75mcg
dose is lacking and requires further assessment for routine use as a first-line option.
1. Arcapta (indacaterol) Professional Product Label. At: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf
Accessed November 21, 2011.
U.S. Food and Drug Administration. Arcapta (indacaterol): FDA
approves Arcapta Neohaler to treat chronic obstructive pulmonary disease [Internet]. [updated 2011
July 1; cited 2011 Nov 1]. Available from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm
3. European Medicines Agency. European Public Assessment Report (EPAR) for Onbrez Breezhaler
(indacaterol). Available at: http://www.ema.europa.eu/docs/en
_GB/document_library/EPAR_-_Summary_for_the_public/human/001114/WC500053733.pdf. Accessed 21
4. Centers for Disease Control and Prevention. Fast Stats: Death and Mortality [Internet].
[updated 2011 Oct 24; cited 2011 Nov 21]. Available from http://www.cdc.gov/nchs/fastats/deaths.htm
initiative for chronic obstructive lung disease (GOLD). Global Strategy for the Diagnosis,
Management, and Prevention of chronic obstructive pulmonary disease (accessed November, 2011).
Available from www.goldcopd.com
6. Donohue JF, Fogarty C, Lotvall J, et al. Once-daily bronchodilators for chronic
obstructive pulmonary disease. Am J Respir Crit Care Med 2010;182:155-162.
TR, Zaiken K. Management of chronic obstructive pulmonary disease: An emphasis on recently approved
medications and products in the pipeline. Formulary 2011;46:374-393.