GSK preparing submissions for Nucala in COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it will submit regulatory applications this year for Nucala mepolizumab (SB-240563) to treat eosinophilic chronic obstructive pulmonary disease after reporting mixed data from the Phase III METREX and METREO trials.

In METREX, 100 mg mepolizumab given every four weeks significantly reduced the mean annual rate of moderate and severe exacerbations compared to placebo, meeting the primary endpoint (1.4 vs. 1.71 exacerbations per year, p=0.036). Mepolizumab also met the secondary endpoint of increasing the time to first moderate and severe exacerbation, but missed the secondary endpoints of reducing the annual rate of exacerbations requiring hospitalization, St. George’s Respiratory Questionnaire (SGRQ) score and COPD assessment score vs. placebo...