Fluticasone furoate/vilanterol

Fluticasone furoate/vilanterol (FF/VI), sold under the trade names Breo Ellipta among others, is a combination medication for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β2 agonist (ultra-LABA).

Fluticasone furoate/vilanterol
Combination of
Fluticasone furoateCorticosteroid
VilanterolUltra-long-acting β2 agonist
Clinical data
Trade namesBreo Ellipta, Relvar Ellipta
AHFS/Drugs.combreo-ellipta
License data
Pregnancy
category
  • US: C (Risk not ruled out)
    Routes of
    administration    		Inhalation (DPI)
    ATC code
    Legal status
    Legal status
    • US: ℞-only
    • In general: ℞ (Prescription only)

    In 2013, the drug was approved for use in the United States by the Food and Drug Administration for long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema,[1] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[2]

    There were, however, concerns that LABAs such as vilanterol increase the risk of deaths due to asthma. In 2017 the FDA states that they were not justified.[1]

    Medical uses

    There is tentative evidence as of 2016 that it is better than placebo for asthma.[3] Evidence is less strong in children.[3]

    History

    Approval

    This drug was approved by the FDA for use as a long-term, once-daily, maintenance treatment in people with COPD in 2013. Labeling changed on April 30, 2015 to add an indication for a once-daily treatment of asthma in people 18 years or older.[4] The exclusivity for a new product ended in May 2016 in the United States, and the exclusivity on the indication for asthma expired on April 30, 2018.[5] The patent for both indications expires on August 3, 2021.[5] The European Medicines Agency approved the drug for marketing on November 13, 2013.[6]

    Commercial information

    GlaxoSmithKline manufactures this drug. As of December 31, 2015, FF/VI inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries.[7] Within the trade name, the "Ellipta" is the dry powder inhaler that the medication is administered in. Innoviva developed the active substance vilanterol, and receives royalties on sales.[8]

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    References
    1. "FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease". Food and Drug Administration. 10 May 2013. Archived from the original on 12 January 2017.
    2. "Summary of opinion: Relvar Ellipta" (PDF). European Medicines Agency. 19 September 2013.
    3. Dwan K, Milan SJ, Bax L, Walters N, Powell C (September 2016). "Vilanterol and fluticasone furoate for asthma". The Cochrane Database of Systematic Reviews. 9: CD010758. doi:10.1002/14651858.CD010758.pub2. PMC 6472525. PMID 27582089.
    4. "US Breo Ellipta label" (PDF). FDA. October 2016. Label history is at FDA website page for NDA 204275
    5. "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Retrieved 2016-11-20.
    6. "European Medicines Agency - Find medicine - Relvar Ellipta". EMA.Europa.eu. Retrieved 2016-11-20.
    7. "Innoviva | Primed for Portfolio Growth". Inva.com. Retrieved 2016-11-20.
    8. "Innoviva Reports Second Quarter 2016 Financial Results | Business Wire". BusinessWire.com. Retrieved 2016-11-20.
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