FDA Approves Breo Ellipta as Asthma Treatment for Adults

The US Food and Drug Administration today announced the approval of fluticasone furoate/vilanterol (Breo Ellipta/GlaxoSmithKline and Theravance Inc) for the once-daily treatment of asthma in patients aged 18 years and older. However, the drug is not indicated for the relief of acute bronchospasm.

According to a news release from GlaxoSmithKline (GSK), Breo Ellipta is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta₂-agonist vilanterol. It will be available in two dosages (100/25mcg and 200/25mcg) and will be administered once-daily using the Ellipta dry powder inhaler.

The FDA declined to approve Breo Elipta for the treatment of asthma in patients age 12-17 years, noting in a complete response letter that “the data submitted do not show adequate risk-benefit to support the approval in these patients,” according to GSK. The FDA will require additional data to be submitted demonstrating safety and efficacy in this population.

GSK cautions physicians treating patients with asthma, to only prescribe Breo Ellipta for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA.

Breo Ellipta was approved in 2013 for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.