The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee have voted 16-4 to recommend the approval of GSK’s Breo Ellipta fluticasone/vilanterol DPI for the treatment of asthma in patients 18 and older.
The FDA approved Breo Ellipta for the treatment of COPD in May 2013, and GSK submitted a supplemental NDA for the asthma indication (in patients 12 and over) in June 2014.
The briefing documents for the meeting focused on safety issues, noting that if the FDA approves the product, vilanterol will be the first new LABA approved for the treatment of asthma in the US in over ten years.
On the question of efficacy in adults aged 18 or over, the panel voted 18 to 2 in agreement; however, for children 12-17 years, the vote was 4 yes and 16 no.
On the question of whether the data adequately demonstrated the safety of Breo Ellipta for adults, the vote was 17 yes, 3 no. For adolescents, the panel voted 19-1 that safety had not been adequately demonstrated.
