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Pulmonary and Allergy Drugs Advisory Committee

On Wednesday, July 25, 2018 the Pulmonary-Allergy Drugs Advisory Committee (PADAC). discussed a supplemental biologics license application (sBLA) for Nucala (mepolizumab), by GlaxoSmithKline (GSK), which proposed use as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts.

·      A majority of the Committee, 16 of 19 members, voted that the benefit-risk profile is not adequate to support approval of mepolizumab for the proposed use.