|Systematic (IUPAC) name|
|Trade names||Onbrez, Arcapta|
|Licence data||EMA: , US FDA:|
|Pregnancy cat.||C (US)|
|Legal status||POM (UK) ℞-only (US)|
|Mol. mass||392.490 g/mol|
|(what is this?)|
Indacaterol (INN) is an ultra-long-acting beta-adrenoceptor agonist developed by Novartis. It was approved by the European Medicines Agency (EMA) under the trade name Onbrez on November 30, 2009, and by the United States Food and Drug Administration (FDA), under the trade name Arcapta Neohaler, on July 1, 2011. It needs to be taken only once a day, unlike the related drugs formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler.
A Phase III trial published in March 2010 examined the efficacy and safety of indacaterol in COPD patients. This study, conducted in the U.S., New Zealand, and Belgium, compared indacaterol dry-powder inhaler to placebo in 416 COPD patients, mostly moderate to severe (mean FEV1 of 1.5 L). Indacaterol produced statistically improved FEV1 (both trough and AUC) and decreased use of rescue medication compared to placebo, but with safety and tolerability similar to those of placebo.
A year-long, placebo-controlled trial published in July 2010 suggests indacaterol may be significantly more effective than twice-daily formoterol in improving FEV1. There were some reductions in the need for rescue medication, but these were not significantly different; nor was there any difference in the rate of exacerbation between the 2 active treatments.
A study published in October, 2011 in the European Respiratory Journal compared indacaterol with tiotropium over the study period of 12 weeks. The study found no statistical difference between the effects of the two drugs on FEV1. Indacaterol yielded greater improvements in transition dyspnoea index (TDI) total score and St. George’s Respiratory Questionnaire (SGRQ) total score.
- Cazzola M, Matera MG, Lötvall J (July 2005). "Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease". Expert Opin Investig Drugs 14 (7): 775–83. doi:10.1517/135437184.108.40.2065. PMID 16022567.
- European Public Assessment Report for Onbrez Breezhaler
- "FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration. 2011-07-01. Retrieved 2011-07-02.
- Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A (May 2007). "Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma". Eur. Respir. J. 29 (5): 871–8. doi:10.1183/09031936.00060006. PMID 17251236.
- Feldman, G; Siler, T; Prasad, N; Jack, D; Piggott, S; Owen, R; Higgins, M; Kramer, B; Study Group, I (2010). "Efficacy and safety of indacaterol 150 mcg once-daily in COPD: a double-blind, randomised, 12-week study". BMC pulmonary medicine 10: 11. doi:10.1186/1471-2466-10-11. PMC 2848004. PMID 20211002.
- Dahl R; Chung KF; Buhl R et al. (June 2010). "Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD". Thorax 65 (6): 473–9. doi:10.1136/thx.2009.125435. PMID 20522841.
- R. Buhl; L.J. Dunn; C. Disdier et al. (October 2011). "Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD". European Respiratory Journal 38 (4): 797–803. doi:10.1183/09031936.00191810. PMID 21622587.