Fluticasone furoate/vilanterol (FF/VI), sold under the trade names Breo Ellipta and Relvar Ellipta, 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 ?2 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.
Video Fluticasone furoate/vilanterol
Medical uses
There is tentative evidence as of 2016 that it is better than placebo for asthma. Evidence is less strong in children.
Maps Fluticasone furoate/vilanterol
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. A labeling change was made 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. However, the exclusivity on the indication for asthma expires 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.
Commercial information
GlaxoSmithKline manufactures this drug. As of December 31, 2015, FF/VI inhalation powder was approved for marketing in 73 countries, and has been launched in 45 countries. Within the trade name, the "Ellipta" is the dry powder inhaler that the medication is administered in. Innoviva developed this inhaler, and receives royalties on sales of this medication. They declared a 118% increase from 2015 in royalty payments from GSK for the third quarter of 2016.
References
Source of the article : Wikipedia
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