Fluticasone furoate/vilanterol

Fluticasone furoate/vilanterol, sold under the brand names Breo Ellipta and Relvar Ellipta among others, is a combination medication for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.^[3][4] It contains fluticasone furoate, an inhaled corticosteroid, and vilanterol, an ultra-long-acting β₂ agonist (ultra-LABA).^[3][4]

Fluticasone furoate/vilanterol

Combination of
Fluticasone furoate	Corticosteroid
Vilanterol	Ultra-long-acting β2 agonist
Clinical data
Trade names	Breo Ellipta, Relvar Ellipta, others
Other names	FF/VI
AHFS/Drugs.com	breo-ellipta
License data	US DailyMed: Fluticasone and vilanterol
Routes of administration	Inhalation
ATC code	R03AK10 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1] UK: POM (Prescription only)[2] US: ℞-only[3] EU: Rx-only[4][5] In general: ℞ (Prescription only)
Identifiers
KEGG	D10501

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,^[6] and the European Medicines Agency approved it as a second-line therapy for the treatment of COPD and asthma.^[7] 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.^[6]

It is on the World Health Organization's List of Essential Medicines.^[8] In 2022, it was the 145th most commonly prescribed medication in the United States, with more than 3 million prescriptions.^[9][10]

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.^[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.^[11] The patent for both indications expired in August 2021.^[11] The European Medicines Agency authorized the combination for marketing in November 2013.^[12]

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.^[13] 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.^[14]

Research

There is tentative evidence as of 2016, that it is better than placebo for asthma.^[15] Evidence is less strong in children.^[15]