Briefing Summary: US FDA Posts Advisory Committee Materials for GlaxoSmithKline’s Mepolizumab for Severe Eosinophilic Asthma – JUN 11, 2015 (PADAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, June 11, 2015 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting. The Committee will discuss mepolizumab for injection, submitted by GlaxoSmithKline for the proposed indication of add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma, identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months.