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Fluticasone furoate/vilanterol

Fluticasone furoate/vilanterol, sold under the brand names Breo Ellipta and Relvar Ellipta among others, is a combination medication for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.[3][4] It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β2 agonist (ultra-LABA).[3][4]

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,[6] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[7] 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.[6]

It is on the World Health Organization's List of Essential Medicines.[8] In 2023, it was the 139th most commonly prescribed medication in the United States, with more than 4million prescriptions.[9][10]

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 aged 18 years of age and 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.[11] The patent for both indications expired in August 2021.[11] The European Medicines Agency authorized the combination for marketing in November 2013.[12]

Society and culture

Commercial information

GlaxoSmithKline manufactures the combination. As of December 2015, fluticasone furoate/vilanterol inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries.[13] 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.[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. 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. Breo Ellipta- fluticasone furoate and vilanterol trifenatate powder DailyMed, retrieved 23 March 2021^
  4. Relvar Ellipta EPAR European Medicines Agency (EMA), 10 December 2013, retrieved 23 March 2021^
  5. Revinty Ellipta European Medicines Agency (EMA), 2 May 2014, retrieved 4 September 2024^
  6. FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease Food and Drug Administration, 10 May 2013^
  7. Summary of opinion: Relvar Ellipta European Medicines Agency, 19 September 2013, retrieved 11 March 2014^
  8. The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) World Health Organization, 2023^
  9. Top 300 of 2023 ClinCalc, retrieved 12 August 2025^
  10. Fluticasone; Vilanterol Drug Usage Statistics, United States, 2013 - 2023 ClinCalc, retrieved 18 August 2025^
  11. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations www.accessdata.fda.gov, retrieved 20 November 2016^
  12. European Medicines Agency - Find medicine - Relvar Ellipta EMA.Europa.eu, retrieved 20 November 2016^
  13. Innoviva Inva, retrieved 20 November 2016^
  14. Innoviva Reports Second Quarter 2016 Financial Results Business Wire, 28 July 2016, retrieved 20 November 2016^
  15. Vilanterol and fluticasone furoate for asthma The Cochrane Database of Systematic Reviews, September 2016^