FDA Offers Mixed Opinion of sNDA for GSK’s Respiratory Drug
GlaxoSmithKline (GSK) and Theravance, Inc. announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) regarding the supplemental new drug application (sNDA) for Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as a once-daily inhaled treatment for asthma in patients aged 12 years and older.
Breo, a fixed-dose combination of the inhaled corticosteroid FF and the long-acting beta2-agonist (LABA) VI, is administered with the Ellipta dry-powder inhaler device. The sNDA for Breo Elliptain asthma was submitted to the FDA in June 2014 for two once-daily dose regimens, 100/25 mcg and 200/25 mcg.
The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older. The committee voted against approval for the proposed indication in 12-17 year olds, citing that the efficacy data was not sufficient to demonstrate the benefit and that the safety has not been adequately demonstrated in this sub-population.
The committee recommended that a large LABA safety trial with FF/VI should be required in adults and in 12-17 year olds similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA-containing asthma treatments.
The FDA advisory committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30, 2015, the Prescription Drug User Fee Act goal date.
Breo Ellipta (FF/VI 100/25 mcg) was licensed by the FDA under the brand name Breo Ellipta 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, including chronic bronchitis and/or emphysema. Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US.