Fluticasone furoate/vilanterol

Fluticasone furoate/vilanterol (FF/VI), sold under the brand name Breo Ellipta among others, is a combination medication for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.[2] It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β2 agonist (ultra-LABA).[2]

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
Routes of
administration		Inhalation (DPI)
ATC code
Legal status
Legal status
  • UK: POM (Prescription only) [1]
  • US: ℞-only [2]
  • EU: Rx-only [3]
  • In general: ℞ (Prescription only)
Identifiers
KEGG

In 2013, the drug was approved for use in the United States by the Food and Drug Administration (FDA) for long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema,[4] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[5] 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.[4]

It is on the World Health Organization's List of Essential Medicines.[6] In 2020, it was the 115th most commonly prescribed medication in the United States, with more than 5 million prescriptions.[7][8]

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 30 April 2015, to add an indication for a once-daily treatment of asthma in people 18 years or older.[2] The exclusivity for a new product ended in May 2016, in the United States, and the exclusivity on the indication for asthma expired on 30 April 2018.[9] The patent for both indications expires on 3 August 2021.[9] The European Medicines Agency approved the drug for marketing on 13 November 2013.[10]

Society and culture

Commercial information

GlaxoSmithKline manufactures this drug. As of 31 December 2015, FF/VI inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries.[11] 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.[12]

Research

There is tentative evidence as of 2016 that it is better than placebo for asthma.[13] Evidence is less strong in children.[13]

References
  1. "Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed - Summary of Product Characteristics (SmPC)". (emc). 7 December 2020. Retrieved 23 March 2021.
  2. "Breo Ellipta- fluticasone furoate and vilanterol trifenatate powder". DailyMed. Retrieved 23 March 2021.
  3. "Relvar Ellipta EPAR". European Medicines Agency (EMA). Retrieved 23 March 2021.
  4. "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.
  5. "Summary of opinion: Relvar Ellipta" (PDF). European Medicines Agency. 19 September 2013.
  6. World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  7. "The Top 300 of 2020". ClinCalc. Retrieved 7 October 2022.
  8. "Fluticasone; Vilanterol - Drug Usage Statistics". ClinCalc. Retrieved 7 October 2022.
  9. "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Retrieved 20 November 2016.
  10. "European Medicines Agency - Find medicine - Relvar Ellipta". EMA.Europa.eu. Retrieved 20 November 2016.
  11. "Innoviva | Primed for Portfolio Growth". Inva.com. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  12. "Innoviva Reports Second Quarter 2016 Financial Results | Business Wire". BusinessWire.com. 28 July 2016. Retrieved 20 November 2016.
  13. 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.
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