Background Analysis: US FDA Advisory Committee to Review GlaxoSmithKline’s Breo Ellipta – MAR 19, 2015 (PADAC)
The US FDA has scheduled a Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) for Thursday, March 19, 2015. The committees will discuss a supplemental new drug application for fluticasone furoate and vilanterol 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 discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended. Breo Ellipta is in development under a collaboration agreement between Glaxo Group Limited and Theravance, Inc.