Briefing Summary: US FDA Posts Advisory Committee Materials for GlaxoSmithKline’s Breo Ellipta for Asthma – MAR 19, 2015 (PADAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, March 19, 2015 Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSRM). The committee 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.

See the SAC Tracker Report