Indacaterol is an ultra-long-acting beta-adrenoceptor agonist[5] developed by Novartis. It needs to be taken only once a day,[6] 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 through a dry powder inhaler.[7]
Medical uses
A Cochrane review found benefit in lung function in people with COPD at least as good as that seen with twice-daily long-acting beta2-agonists.[8]
Pharmacology
Pharmacodynamics
| Receptor | Ki (nM) | EC50 (nM) | Emax (%)a |
|---|---|---|---|
| β1 | 617 | 251 | 16%a |
| β2 | 43.7 | 8.71 | 73%a |
| β3 | 3,310 | 191 | 113%a |
| Footnotes: a = Compared to isoprenaline (isoproterenol). Refs: [9] | |||
Indacaterol is a long-acting selective β2-adrenergic receptor agonist.[10][9]
History
It was approved by the European Medicines Agency (EMA) under the brand name Onbrez Breezhaler on November 30, 2009,[11] and by the United States Food and Drug Administration (FDA), under the brand name Arcapta Neohaler, on July 1, 2011.[12][13] In 2016, Novartis licensed its U.S. commercial rights for Arcapta Neohaler to Sunovion Pharmaceuticals.[14]
See also
References
- ↑ "Arcapta Neohaler (indacaterol) inhalation powder Initial U.S. Approval: 2011". DailyMed. 1 April 2020. Retrieved 14 June 2021.
- ↑ "Onbrez Breezhaler EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 20 January 2021.
- ↑ "Oslif Breezhaler EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 20 January 2021.
- ↑ "Hirobriz Breezhaler EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 20 January 2021.
- ↑ 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:10.1517/13543784.14.7.775. PMID 16022567. S2CID 11930383.
- ↑ 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.
- ↑ "Indacaterol (Arcapta Neohaler) National Drug Monograph" (PDF). VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives.
- ↑ Geake JB (2015). "Indacaterol, a once-daily beta2-agonist, versus twice-daily beta2-agonists or placebo for chronic obstructive pulmonary disease". Reviews. 1 (3) CD010139. doi:10.1002/14651858.CD010139.pub2. PMC 6464646. PMID 25575340.
- 1 2 Battram C, Charlton SJ, Cuenoud B, Dowling MR, Fairhurst RA, Farr D, et al. (May 2006). "In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled beta(2) adrenoceptor agonist with a 24-h duration of action". The Journal of Pharmacology and Experimental Therapeutics. 317 (2): 762–770. doi:10.1124/jpet.105.098251. PMID 16434564.
- ↑ Beeh KM, Beier J (June 2010). "Indacaterol: a new once daily long-acting beta(2) adrenoceptor agonist". Core Evid. 4: 37–41. doi:10.2147/ce.s6013. PMC 2899782. PMID 20694063.
- ↑ "European Public Assessment Report for Onbrez Breezhaler". Archived from the original on 2010-01-16.
- ↑ "FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration. 2011-07-01. Archived from the original on 2011-07-03. Retrieved 2011-07-02.
- ↑ "Drug Approval Package: Arcapta Neohaler (indacaterol maleate) NDA #022383". U.S. Food and Drug Administration. 13 August 2013. Archived from the original on October 27, 2020. Retrieved 14 June 2021.
- ↑ Faulkner S (22 December 2016). "Sunovion, Novartis ink licensing deal for inhaled COPD drugs". Drug Delivery Business.