Fluticasone furoate/vilanterol

Fluticasone furoate/vilanterol
Combination of
Fluticasone furoateCorticosteroid
VilanterolLong-acting β2 agonist
Names
Trade namesBreo Ellipta, Relvar Ellipta
Clinical data
Main usesCOPD, asthma[1]
Side effectsThrush, headache, upper respiratory tract infection, cough, throat pain, pneumonia, bronchospasm, glaucoma, low potassium[1]
Routes of
use		Inhalation
External links
AHFS/Drugs.combreo-ellipta
Legal
License data
Legal status
  • AU: S4 (Prescription only) [2]
  • UK: POM (Prescription only) [3]
  • US: ℞-only [1]
  • EU: Rx-only [4]
  • In general: ℞ (Prescription only)

Fluticasone furoate/vilanterol (FF/VI), sold under the brand name Breo Ellipta among others, is a combination medication used for long-term treatment of chronic obstructive pulmonary disease (COPD) and asthma.[1] In Europe it as a second-line therapy.[5] It is used by breathing it in through the mouth.[1]

Common side effects include thrush, headache, upper respiratory tract infection, cough, and throat pain.[1] Other side effects may include pneumonia, bronchospasm, glaucoma, and low potassium.[1] It contains fluticasone furoate, a corticosteroid, and vilanterol, a long-acting β2 agonist (LABA).[1] There are concerns that a LABA alone may worsen outcomes in asthma.[1]

The combination was approved for medical use in the United States and Europe in 2013.[1][4] It is on the World Health Organization's List of Essential Medicines as an alternative to budesonide/formoterol.[6] It is available as a generic medication.[7] In the United States it costs about 160 USD for 60 doses as of 2023.[7] The amount in the United Kingdom costs the NHS about £44.[8] In 2020, it was the 115th most commonly prescribed medication in the United States, with more than 5 million prescriptions.[9][10]

Medical uses

Dosage

It is used as one inhalation once per day.[4]

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.[1] 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.[11] The patent for both indications expires on 3 August 2021.[11] The European Medicines Agency approved the drug for marketing on 13 November 2013.[12]

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.[13] 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.[14]

Research

There is tentative evidence as of 2016 that it is better than placebo for asthma.[15] Evidence is less strong in children.[15]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 "Breo Ellipta- fluticasone furoate and vilanterol trifenatate powder". DailyMed. Archived from the original on 26 May 2020. Retrieved 23 March 2021.
  2. ↑ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  3. ↑ "Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed - Summary of Product Characteristics (SmPC)". (emc). 7 December 2020. Archived from the original on 5 February 2020. Retrieved 23 March 2021.
  4. 1 2 3 "Relvar Ellipta EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 5 February 2020. Retrieved 23 March 2021.
  5. ↑ "Summary of opinion: Relvar Ellipta" (PDF). European Medicines Agency. 19 September 2013. Archived (PDF) from the original on 24 September 2015. Retrieved 28 May 2023.
  6. ↑ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  7. 1 2 "Generic Breo Ellipta". GoodRx. Archived from the original on 25 April 2020. Retrieved 9 September 2023.
  8. ↑ "Fluticasone with vilanterol Medicinal forms". NICE. Archived from the original on 10 September 2023. Retrieved 9 September 2023.
  9. ↑ "The Top 300 of 2020". ClinCalc. Archived from the original on 12 February 2021. Retrieved 7 October 2022.
  10. ↑ "Fluticasone; Vilanterol - Drug Usage Statistics". ClinCalc. Archived from the original on 10 October 2022. Retrieved 7 October 2022.
  11. 1 2 "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  12. ↑ "European Medicines Agency - Find medicine - Relvar Ellipta". EMA.Europa.eu. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  13. ↑ "Innoviva | Primed for Portfolio Growth". Inva.com. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  14. ↑ "Innoviva Reports Second Quarter 2016 Financial Results | Business Wire". BusinessWire.com. 28 July 2016. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
  15. 1 2 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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