Results Wire: US FDA Advisory Committee Unanimously Supports GlaxoSmithKline’s Mepolizumab for Severe Eosinophilic Asthma in Adults – JUN 11, 2015 (PADAC)

On Thursday, June 11, 2015 the Pulmonary-Allergy Drugs Advisory Committee (PADAC) supported, by a unanimous vote of 14-Yes, and 0-No, with no abstentions, the safety and efficacy of GlaxoSmithKline’s (GSK) mepolizumab for add-on maintenance treatment in adult patients 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. The Committee did not support this use in patients aged 12-17 years, by a vote of 4-Yes and 10-No.

See the SAC Tracker report