Results Wire: US FDA Advisory Committee Supports GlaxoSmithKline’s Breo Ellipta For Adults, Not For Adolescents – MAR 19, 2015 (PADAC)
On Thursday, March 19, 2015 the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) met jointly to discuss a supplemental new drug application for fluticasone furoate (FF) and vilanterol (VI) inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline (GSK) for the once-daily maintenance treatment of asthma in patients 12 years of age and older. The committee supported, by a vote of 18–Yes, 2-No, the effectiveness of the drug for adult patients. The committee did not support, by a vote of 4–Yes, 16-No, the effectiveness of the drug for adolescent patients (aged 12 – 17 years). The committee supported, by a vote of 17–Yes, 3-No, the safety of the drug for adult patients. The committee did not support, by a vote of 1–Yes, 19-No, the safety of the drug for adolescent patients (aged 12 – 17 years). The committee supported, by a vote of 16–Yes, 4-No, approval of the drug for adult patients. The committee did not support, by a vote of 1–Yes, 19-No, approval of the drug for adolescent patients (aged 12 – 17 years). The committee recommended, by a vote of 13-Yes, 7-No, requiring a large LABA safety trial with FF/VI, similar to the ongoing LABA safety trials in adults 18 years and older. The committee also recommended, by a vote of 17-Yes, 2-No, with 1 abstention, requiring a large LABA safety trial with FF/VI similar to the ongoing LABA safety trials in children 12-17 years of age.