Fluticasone furoate/vilanterol
{{Short description|Pharmaceutical drug formulation}}
{{Use dmy dates|date=October 2022}}
{{Drugbox
| type = combo
| image = Fluticasone furoate and vilanterol.svg
| width = 180
| alt =
| component1 = Fluticasone furoate
| class1 = Corticosteroid
| component2 = Vilanterol
| class2 = Ultra-long-acting β2 agonist
| tradename = Breo Ellipta, Relvar Ellipta, others
| Drugs.com = {{Drugs.com|parent|breo-ellipta}}
| MedlinePlus =
| DailyMedID = Fluticasone and vilanterol
| pregnancy_AU =
| pregnancy_category =
| routes_of_administration = Inhalation
| ATC_prefix = R03
| ATC_suffix = AK10
| legal_AU = S4
| legal_CA =
| legal_UK = POM
| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Relvar Ellipta EPAR | website=European Medicines Agency (EMA) | date=10 December 2013 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/relvar-ellipta | access-date=23 March 2021}}{{cite web | title=Revinty Ellipta | website=European Medicines Agency (EMA) | date=2 May 2014 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/revinty-ellipta | access-date=4 September 2024}}
| legal_status = Rx-only
| CAS_number =
| PubChem =
| DrugBank =
| KEGG = D10501
| synonyms = FF/VI
}}
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,{{cite web | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm | title = FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease | publisher = Food and Drug Administration | date = 10 May 2013 | url-status = dead | archive-url = https://web.archive.org/web/20170112023857/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm | archive-date = 12 January 2017}} and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.{{cite web | url=http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002673/WC500150090.pdf | title=Summary of opinion: Relvar Ellipta | publisher=European Medicines Agency | date=19 September 2013 | access-date=11 March 2014 | archive-date=24 September 2015 | archive-url=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 | url-status=dead }} 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.{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }} In 2022, it was the 145th most commonly prescribed medication in the United States, with more than 3{{nbsp}}million prescriptions.{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}{{cite web | title = Fluticasone; Vilanterol Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/FluticasoneVilanterol | access-date = 30 August 2024 }}
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. 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.{{Cite web|url=http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=204275&Appl_type=N|archive-url=https://web.archive.org/web/20161121052024/http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=204275&Appl_type=N|url-status=dead|archive-date=21 November 2016|title=Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations|website=www.accessdata.fda.gov|access-date=20 November 2016}} The patent for both indications expired in August 2021. The European Medicines Agency authorized the combination for marketing in November 2013.{{Cite web|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002673/human_med_001708.jsp&mid=WC0b01ac058001d124|title=European Medicines Agency - Find medicine - Relvar Ellipta|website=EMA.Europa.eu|access-date=20 November 2016|archive-date=21 November 2016|archive-url=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|url-status=dead}}
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.{{Cite web|url=http://www.inva.com/portfolio/|title=Innoviva |website=Inva |access-date=20 November 2016|archive-date=21 November 2016|archive-url=https://web.archive.org/web/20161121103354/http://www.inva.com/portfolio/|url-status=dead}} 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.{{Cite web|url=http://www.businesswire.com/news/home/20160728006469/en/Innoviva-Reports-Quarter-2016-Financial-Results|title=Innoviva Reports Second Quarter 2016 Financial Results |website=Business Wire |date=28 July 2016|access-date=20 November 2016}}
Research
There is tentative evidence as of 2016, that it is better than placebo for asthma.{{cite journal | vauthors = Dwan K, Milan SJ, Bax L, Walters N, Powell C | title = Vilanterol and fluticasone furoate for asthma | journal = The Cochrane Database of Systematic Reviews | volume = 9 | pages = CD010758 | date = September 2016 | issue = 9 | pmid = 27582089 | pmc = 6472525 | doi = 10.1002/14651858.CD010758.pub2 }} Evidence is less strong in children.
References
{{Reflist}}
{{Drugs for obstructive airway diseases}}
{{GlaxoSmithKline}}
{{Portal bar | Medicine}}
{{DEFAULTSORT:Fluticasone Furoate Vilanterol}}
Category:Drugs acting on the respiratory system
Category:Long-acting beta2-adrenergic agonists