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]
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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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