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. 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 (FDA) for long-term maintenance treatment of airflow obstruction in people 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 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.

It is on the World Health Organization's List of Essential Medicines. In 2023, it was the 139th most commonly prescribed medication in the United States, with more than 4 million prescriptions.

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. 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.