GlaxoSmithKline and Theravance announced that the Food and Drug Administration (FDA) has approved Breo Ellipta (fluticasone furoate/vilanterol) for the once-daily treatment of asthma in patients aged ≥18 years.
The approval of the supplemental New Drug Application (sNDA) in patients aged ≥18 years was based on the results of a clinical trial of over 12,000 patients in 23 studies of patients aged ≥12. The FDA issued a complete response letter in regards to the proposed use of Breo Ellipta in patients aged 12–17, stating that additional data would be required to further demonstrate the safety and efficacy of the product in this population.
Breo Ellipta is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, and the long-acting beta2-agonist (LABA) vilanterol. The combination inhaler works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with asthma.
Breo Ellipta is already indicated for long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations in patients aged ≥18.
Breo Ellipta dry powder inhaler for asthma has been approved for 100mcg/25mcg and 200mcg/25mcg strengths.
For more information visit MyBreo.com.