Background Analysis: US FDA Advisory Committee to Review GlaxoSmithKline’s Mepolizumab for Severe Eosinophilic Asthma – JUN 11, 2015 (PADAC)
The US FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee (PADAC) Meeting for Thursday, June 11, 2015, to discuss biologics license application (BLA) 125526, for 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.