Fluticasone furoate/vilanterol
Fluticasone furoate/vilanterol (FF/VI), sold under the trade names 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).
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Combination of | |
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Fluticasone furoate | Corticosteroid |
Vilanterol | Ultra-long-acting β2 agonist |
Clinical data | |
Trade names | Breo Ellipta, Relvar Ellipta |
AHFS/Drugs.com | breo-ellipta |
License data | |
Routes of administration | Inhalation (DPI) |
ATC code | |
Legal status | |
Legal status |
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In 2013, the drug was approved for use in the United States by the Food and Drug Administration for long-term maintenance treatment of airflow obstruction in patients 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.[1]
Medical uses
There is tentative evidence as of 2016 that it is better than placebo for asthma.[3] Evidence is less strong in children.[3]
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 April 30, 2015 to add an indication for a once-daily treatment of asthma in people 18 years or older.[4] The exclusivity for a new product ended in May 2016 in the United States, and the exclusivity on the indication for asthma expired on April 30, 2018.[5] The patent for both indications expires on August 3, 2021.[5] The European Medicines Agency approved the drug for marketing on November 13, 2013.[6]
Commercial information
GlaxoSmithKline manufactures this drug. As of December 31, 2015, FF/VI inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries.[7] 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.[8]
References
- "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.
- 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: CD010758. doi:10.1002/14651858.CD010758.pub2. PMC 6472525. PMID 27582089.
- "US Breo Ellipta label" (PDF). FDA. October 2016. Label history is at FDA website page for NDA 204275
- "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations". www.accessdata.fda.gov. Retrieved 2016-11-20.
- "European Medicines Agency - Find medicine - Relvar Ellipta". EMA.Europa.eu. Retrieved 2016-11-20.
- "Innoviva | Primed for Portfolio Growth". Inva.com. Retrieved 2016-11-20.
- "Innoviva Reports Second Quarter 2016 Financial Results | Business Wire". BusinessWire.com. Retrieved 2016-11-20.