|Vilanterol||Ultra-long-acting β2 agonist|
|Trade names||Breo Ellipta, Relvar Ellipta|
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).
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, and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.
There are, however, concerns that LABAs such as vilanterol increase the risk of deaths due to asthma.
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. 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. The patent for both indications expires on August 3, 2021. The European Medicines Agency approved the drug for marketing on November 13, 2013.
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. 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.
- "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 (1 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". www.ema.europa.eu. Retrieved 2016-11-20.
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