A joint meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted to recommend approval of GlaxoSmithKline (GSK) and Theravance's Breo Ellipta (fluticasone furoate/vilanterol) for asthma support treatment in adults. The committees voted against approval for the treatment of asthma in children aged 12-17 years, concluding that there was currently insufficient evidence of efficacy and safety in this population.
They recommended that a large safety trial be conducted in adults and in subjects aged 12-17 years. The FDA's decision on the sNDA, which was submitted in June 2014, is expected by April 30, 2015. BreoEllipta was approved in the U.S. for treatment of chronic obstructive pulmonary disease (COPD) in May 2013 (Theravance News Release).