Indacaterol Explained

Indacaterol is an ultra-long-acting beta-adrenoceptor agonist[1] developed by Novartis. It needs to be taken only once a day,[2] 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.[3]

History

It was approved by the European Medicines Agency (EMA) under the brand name Onbrez Breezhaler on November 30, 2009,[4] and by the United States Food and Drug Administration (FDA), under the brand name Arcapta Neohaler, on July 1, 2011.[5] [6] In 2016, Novartis licensed its U.S. commercial rights for Arcapta Neohaler to Sunovion Pharmaceuticals.[7]

Notes and References

  1. Cazzola M, Matera MG, Lötvall J . 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 . 16022567 . 10.1517/13543784.14.7.775 . 11930383 .
  2. Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A . Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma . Eur. Respir. J. . 29 . 5 . 871–8 . May 2007 . 17251236 . 10.1183/09031936.00060006 . free .
  3. 10.1002/14651858.CD010139.pub2 . 25575340 . 6464646 . Indacaterol, a once-daily beta2-agonist, versus twice-daily beta2-agonists or placebo for chronic obstructive pulmonary disease . Reviews . 1 . CD010139 . Geake . James B. 2015 . 3 .
  4. http://www.ema.europa.eu/humandocs/Humans/EPAR/onbrez_breezhaler/onbrez_breezhaler.htm European Public Assessment Report for Onbrez Breezhaler
  5. FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease . U.S. Food and Drug Administration . 2011-07-01 . 2011-07-02 . 2011-07-03 . https://web.archive.org/web/20110703185258/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm . dead .
  6. Web site: Drug Approval Package: Arcapta Neohaler (indacaterol maleate) NDA #022383 . U.S. Food and Drug Administration . 13 August 2013 . 14 June 2021 .
  7. Web site: Faulkner . Sarah . Sunovion, Novartis ink licensing deal for inhaled COPD drugs . Drug Delivery Business . 22 December 2016.

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