FDA's Pulmonary-Allergy Drugs Advisory Committee has scheduled a July 25 meeting to discuss an NDA for Nucala mepolizumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). 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 chronic obstructive pulmonary disease guided by blood eosinophil counts.
Last year, GSK said Nucala met the primary endpoint in one Phase III study to treat eosinophilic COPD, but missed the primary endpoint in another. The company said a meta-analysis showed that the rate of exacerbation reduction increased as baseline blood eosinophil counts increased, suggesting that blood eosinophil levels could be used as a biomarker to identify COPD patients most likely to respond to mepolizumab (see BioCentury Extra, Sept. 12, 2017).
FDA has approved Nucala to treat severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).