Committee votes no on GSK's Nucala for COPD

FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against approval of Nucala mepolizumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat chronic obstructive pulmonary disease based on efficacy data and the drug's benefit-risk profile. The company is seeking Nucala's approval as an add-on therapy to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD guided by blood eosinophil counts.

The panel voted 16-3 in two separate votes that efficacy data do not support Nucala’s approval in the indication and that the drug’s benefit-risk profile is not adequate to support approval. The committee also voted 17-2 that safety data are adequate to support its approval...