Chemistry:Indacaterol
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| Trade names | Onbrez, Arcapta |
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| Routes of administration | Inhalation |
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| Formula | C24H28N2O3 |
| Molar mass | 392.499 g·mol−1 |
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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 as an aerosol formulation through a dry powder inhaler.
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.[7]
History
It was approved by the European Medicines Agency (EMA) under the brand name Onbrez Breezhaler on November 30, 2009,[8] and by the United States Food and Drug Administration (FDA), under the brand name Arcapta Neohaler, on July 1, 2011.[9][10] In 2016, Novartis licensed its U.S. commercial rights for Arcapta Neohaler to Sunovion Pharmaceuticals.[11]
References
- ↑ "Arcapta Neohaler (indacaterol) inhalation powder Initial U.S. Approval: 2011". 1 April 2020. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=490657.
- ↑ "Onbrez Breezhaler EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/onbrez-breezhaler.
- ↑ "Oslif Breezhaler EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/oslif-breezhaler.
- ↑ "Hirobriz Breezhaler EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hirobriz-breezhaler.
- ↑ "Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease". Expert Opin Investig Drugs 14 (7): 775–83. July 2005. doi:10.1517/13543784.14.7.775. PMID 16022567.
- ↑ "Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma". Eur. Respir. J. 29 (5): 871–8. May 2007. doi:10.1183/09031936.00060006. PMID 17251236.
- ↑ Geake, James B (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. PMID 25575340.
- ↑ 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. Archived from the original on 2011-07-03. Retrieved 2011-07-02.
- ↑ "Drug Approval Package: Arcapta Neohaler (indacaterol maleate) NDA #022383". 13 August 2013. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000TOC.cfm.
- ↑ Faulkner, Sarah (22 December 2016). "Sunovion, Novartis ink licensing deal for inhaled COPD drugs". https://www.drugdeliverybusiness.com/sunovion-novartis-ink-licensing-deal-inhaled-copd-drugs/.
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