- GlaxoSmithKline (NYSE:GSK) announces the publication of complete results from Phase 3 studies assessing Nucala (mepolizumab) for the treatment of patients with chronic obstructive pulmonary disease (COPD). The data from the METREX and METREO clinical trials have been published in the New England Journal of Medicine with simultaneous presentation at the European Respiratory Society (ERS) International Congress in Milan.
- The studies were designed to assess the safety and efficacy of mepolizumab as add-on therapy aimed at reducing moderate-to-severe COPD attacks in high-risk patients and to identify COPD patients most likely to respond to treatment using blood eosinophils.
- METREX showed treatment with mepolizumab produced a statistically significant 18% reduction in the frequency of exacerbations (p=0.036). METREO showed a 20% reduction but it was not statistically valid (p=0.068). Patients most likely to respond to treatment had blood eosinophil counts of at least 150 cells/microliter at study entry or at least 300 cells/microliter within the past year.
- Mepolizumab is a humanized IgG monoclonal antibody that binds to interleukin 5 (IL-5), a cytokine that plays a key role in regulating the function of eosinophils, white blood cells that cause airway inflammation.
- Regulatory applications should be filed in Q4.
- Previously: Glaxo files U.S. marketing application for expanded use of asthma med Nucala (June 28)
- Now read: GlaxoSmithKline Dividends Look More Attractive With New Management At The Helm
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