Fluticasone furoate/vilanterol explained

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. It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β2 agonist (ultra-LABA).

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,[1] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[2] 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.

It is on the World Health Organization's List of Essential Medicines.[3] In 2021, it was the 108th most commonly prescribed medication in the United States, with more than 5million prescriptions.[4] [5]

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. 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.[6] The patent for both indications expired on 3 August 2021. The European Medicines Agency approved the drug for marketing on 13 November 2013.[7]

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.[8] 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.[9]

Research

There is tentative evidence as of 2016, that it is better than placebo for asthma.[10] Evidence is less strong in children.

Notes and References

  1. Web site: FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease . . 10 May 2013 . dead . https://web.archive.org/web/20170112023857/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm . 12 January 2017.
  2. Web site: Summary of opinion: Relvar Ellipta . . 19 September 2013 . 11 March 2014 . 24 September 2015 . https://web.archive.org/web/20150924041906/http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002673/WC500150090.pdf . dead .
  3. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 22nd list (2021) . 2021 . 10665/345533 . World Health Organization . World Health Organization . Geneva . WHO/MHP/HPS/EML/2021.02 . free .
  4. Web site: The Top 300 of 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  5. Web site: Fluticasone; Vilanterol - Drug Usage Statistics . ClinCalc . 14 January 2024.
  6. Web site: Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. www.accessdata.fda.gov. 20 November 2016.
  7. Web site: European Medicines Agency - Find medicine - Relvar Ellipta. EMA.Europa.eu. 20 November 2016. 21 November 2016. https://web.archive.org/web/20161121042949/http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Fhuman%2Fmedicines%2F002673%2Fhuman_med_001708.jsp&mid=WC0b01ac058001d124. dead.
  8. Web site: Innoviva . Inva . 20 November 2016. 21 November 2016. https://web.archive.org/web/20161121103354/http://www.inva.com/portfolio/. dead.
  9. Web site: Innoviva Reports Second Quarter 2016 Financial Results . Business Wire . 28 July 2016. 20 November 2016.
  10. Dwan K, Milan SJ, Bax L, Walters N, Powell C . Vilanterol and fluticasone furoate for asthma . The Cochrane Database of Systematic Reviews . 9 . CD010758 . September 2016 . 9 . 27582089 . 6472525 . 10.1002/14651858.CD010758.pub2 .

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