FDA Approves New Use for GSK’s Breo Elipta
GlaxoSmithKline plc and Theravance, Inc. have received US Food and Drug Administration (FDA) approval for Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the relief of acute bronchospasm.
Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI). Two strengths, 100/25 mcg and 200/25 mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
The FDA issued a complete response letter related to the proposed use of Breo Ellipta in patients aged 12-17 stating that the data submitted do not show adequate risk-benefit to support the approval in these patients. The FDA stated that additional data would be required to further demonstrate the safety and efficacy in this population.
Breo Ellipta (FF/VI 100/25 mcg) was licensed by the US FDA in May 2013 as a prescription medication 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. A supplemental new drug application for Breo Ellipta in asthma was submitted to the FDA in June 2014, and in April 2015, it was approved for the once-daily treatment of asthma in patients aged 18 years and older.