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,[5] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.[6] 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.[5]
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.[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.[10] The patent for both indications expires on 3 August 2021.[10] The European Medicines Agency approved the drug for marketing on 13 November 2013.[11]
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.[12] 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.[13]
Research
There is tentative evidence as of 2016 that it is better than placebo for asthma.[14] Evidence is less strong in children.[14]
References
^"Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
^"Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed - Summary of Product Characteristics (SmPC)". (emc). 7 December 2020. Retrieved 23 March 2021.
^ abcd"Breo Ellipta- fluticasone furoate and vilanterol trifenatate powder". DailyMed. Retrieved 23 March 2021.
^World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
^"The Top 300 of 2020". ClinCalc. Retrieved 7 October 2022.
^"Fluticasone; Vilanterol - Drug Usage Statistics". ClinCalc. Retrieved 7 October 2022.
^ ab"Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Retrieved 20 November 2016.
^"European Medicines Agency - Find medicine - Relvar Ellipta". EMA.Europa.eu. Retrieved 20 November 2016.
^. Inva.com. Archived from the original on 21 November 2016. Retrieved 20 November 2016.
^"Innoviva Reports Second Quarter 2016 Financial Results | Business Wire". BusinessWire.com. 28 July 2016. Retrieved 20 November 2016.
^ abDwan 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. PMC6472525. PMID 27582089.
External links
"Fluticasone furoate mixture with vilanterol". Drug Information Portal. U.S. National Library of Medicine.
fluticasone, furoate, vilanterol, sold, under, brand, name, breo, ellipta, among, others, combination, medication, treatment, chronic, obstructive, pulmonary, disease, copd, asthma, contains, fluticasone, furoate, inhaled, corticosteroid, vilanterol, ultra, lo. Fluticasone furoate vilanterol FF VI sold under the brand name Breo Ellipta among others is a combination medication for the treatment of chronic obstructive pulmonary disease COPD and asthma 3 It contains fluticasone furoate an inhaled corticosteroid and vilanterol an ultra long acting b2 agonist ultra LABA 3 Fluticasone furoate vilanterolCombination ofFluticasone furoateCorticosteroidVilanterolUltra long acting b2 agonistClinical dataTrade namesBreo Ellipta Relvar ElliptaAHFS Drugs combreo elliptaLicense dataEU EMA by INNRoutes ofadministrationInhalationATC codeR03AK10 WHO Legal statusLegal statusAU S4 Prescription only 1 UK POM Prescription only 2 US only 3 EU Rx only 4 In general Prescription only IdentifiersKEGGD10501In 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 5 and the European Medicines Agency approved it as a second line therapy for the treatment of COPD and asthma 6 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 5 It is on the World Health Organization s List of Essential Medicines 7 In 2020 it was the 115th most commonly prescribed medication in the United States with more than 5 million prescriptions 8 9 Contents 1 History 1 1 Approval 2 Society and culture 2 1 Commercial information 3 Research 4 References 5 External linksHistory EditApproval Edit 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 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 10 The patent for both indications expires on 3 August 2021 10 The European Medicines Agency approved the drug for marketing on 13 November 2013 11 Society and culture EditCommercial information Edit 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 12 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 13 Research EditThere is tentative evidence as of 2016 that it is better than placebo for asthma 14 Evidence is less strong in children 14 References Edit Prescription medicines registration of new chemical entities in Australia 2014 Therapeutic Goods Administration TGA 21 June 2022 Retrieved 10 April 2023 Relvar Ellipta 92 micrograms 22 micrograms inhalation powder pre dispensed Summary of Product Characteristics SmPC emc 7 December 2020 Retrieved 23 March 2021 a b c d Breo Ellipta fluticasone furoate and vilanterol trifenatate powder DailyMed Retrieved 23 March 2021 Relvar Ellipta EPAR European Medicines Agency EMA 17 September 2018 Retrieved 23 March 2021 a b FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease Food and Drug Administration 10 May 2013 Archived from the original on 12 January 2017 Summary of opinion Relvar Ellipta PDF European Medicines Agency 19 September 2013 World Health Organization 2021 World Health Organization model list of essential medicines 22nd list 2021 Geneva World Health Organization hdl 10665 345533 WHO MHP HPS EML 2021 02 The Top 300 of 2020 ClinCalc Retrieved 7 October 2022 Fluticasone Vilanterol Drug Usage Statistics ClinCalc Retrieved 7 October 2022 a b Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations www accessdata fda gov Retrieved 20 November 2016 European Medicines Agency Find medicine Relvar Ellipta EMA Europa eu Retrieved 20 November 2016 Innoviva Primed for Portfolio Growth Inva com Archived from the original on 21 November 2016 Retrieved 20 November 2016 Innoviva Reports Second Quarter 2016 Financial Results Business Wire BusinessWire com 28 July 2016 Retrieved 20 November 2016 a b 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 External links Edit Fluticasone furoate mixture with vilanterol Drug Information Portal U S National Library of Medicine Portal Medicine Retrieved from https en wikipedia org w index php title Fluticasone furoate vilanterol amp oldid 1157472615, wikipedia, wiki, book, books, library,
