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Fluticasone furoate/vilanterol

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Fluticasone furoate/vilanterol
Combination of
Fluticasone furoateCorticosteroid
VilanterolUltra-long-acting β2 agonist
Clinical data
Trade namesBreo Ellipta, Relvar Ellipta
Other namesFF/VI
AHFS/Drugs.combreo-ellipta
License data
Routes of
administration		Inhalation
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)[1]
  • UK: POM (Prescription only)[2]
  • US: ℞-only[3]
  • EU: Rx-only[4]
  • In general: ℞ (Prescription only)
Identifiers
KEGG

Fluticasone furoate/vilanterol, sold under the brand name Breo Ellipta among others, is a combination medication for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.[3] It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β2 agonist (ultra-LABA).[3]

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,[5] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[6] 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.[5]

It is on the World Health Organization's List of Essential Medicines.[7] In 2021, it was the 108th most commonly prescribed medication in the United States, with more than 5 million prescriptions.[8][9]

History

Approval

The combination was approved by the FDA for use as a long-term, once-daily, maintenance treatment in people with COPD in 2013. The FDA label was changed in April 2015, to add an indication for a once-daily treatment of asthma in people 18 years or older.[3] 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.[10] The patent for both indications expired on 3 August 2021.[10] The European Medicines Agency approved the drug for marketing on 13 November 2013.[11]

Society and culture

Commercial information

GlaxoSmithKline manufactures the combination. As of 31 December 2015, fluticasone furoate/vilanterol inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries.[12] Within the brand 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.[13]

Research

There is tentative evidence as of 2016, that it is better than placebo for asthma.[14] Evidence is less strong in children.[14]

References

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed - Summary of Product Characteristics (SmPC)". (emc). 7 December 2020. Retrieved 23 March 2021.
  3. ^ a b c d "Breo Ellipta- fluticasone furoate and vilanterol trifenatate powder". DailyMed. Retrieved 23 March 2021.
  4. ^ "Relvar Ellipta EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 23 March 2021.
  5. ^ a b "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.
  6. ^ "Summary of opinion: Relvar Ellipta" (PDF). European Medicines Agency. 19 September 2013. Archived from the original (PDF) on 24 September 2015. Retrieved 11 March 2014.
  7. ^ 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.
  8. ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  9. ^ "Fluticasone; Vilanterol - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
  10. ^ a b "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Retrieved 20 November 2016.
  11. ^ "European Medicines Agency - Find medicine - Relvar Ellipta". EMA.Europa.eu. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  12. ^ "Innoviva". Inva. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  13. ^ "Innoviva Reports Second Quarter 2016 Financial Results". Business Wire. 28 July 2016. Retrieved 20 November 2016.
  14. ^ a b 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 (9): CD010758. doi:10.1002/14651858.CD010758.pub2. PMC 6472525. PMID 27582089.
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