Combination of | |
---|---|
Fluticasone furoate | Corticosteroid |
Vilanterol | Ultra- long-acting β2 agonist |
Clinical data | |
Trade names | Breo Ellipta, Relvar Ellipta |
Other names | FF/VI |
AHFS/ Drugs.com | breo-ellipta |
License data | |
Routes of administration | Inhalation |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Fluticasone furoate/vilanterol, 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 β2 agonist (ultra-LABA). [3]
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]
It is on the World Health Organization's List of Essential Medicines. [7] In 2021, it was the 108th most commonly prescribed medication in the United States, with more than 5 million prescriptions. [8] [9]
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 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 expired on 3 August 2021. [10] The European Medicines Agency approved the drug for marketing on 13 November 2013. [11]
GlaxoSmithKline manufactures the combination. As of 31 December 2015, fluticasone furoate/vilanterol inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries. [12] 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. [13]
There is tentative evidence as of 2016, that it is better than placebo for asthma. [14] Evidence is less strong in children. [14]
Combination of | |
---|---|
Fluticasone furoate | Corticosteroid |
Vilanterol | Ultra- long-acting β2 agonist |
Clinical data | |
Trade names | Breo Ellipta, Relvar Ellipta |
Other names | FF/VI |
AHFS/ Drugs.com | breo-ellipta |
License data | |
Routes of administration | Inhalation |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Fluticasone furoate/vilanterol, 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 β2 agonist (ultra-LABA). [3]
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]
It is on the World Health Organization's List of Essential Medicines. [7] In 2021, it was the 108th most commonly prescribed medication in the United States, with more than 5 million prescriptions. [8] [9]
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 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 expired on 3 August 2021. [10] The European Medicines Agency approved the drug for marketing on 13 November 2013. [11]
GlaxoSmithKline manufactures the combination. As of 31 December 2015, fluticasone furoate/vilanterol inhalation powder was approved for marketing in 73 countries, and had been launched in 45 countries. [12] 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. [13]
There is tentative evidence as of 2016, that it is better than placebo for asthma. [14] Evidence is less strong in children. [14]