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GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots:

  • The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under review
  • MATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it vs PBO in 836 pts across eosinophilic & non-eosinophilic phenotype group for 52wks.
  • Both trials showed reduced annualized mod. or sev. exacerbation rates in the eosinophilic phenotype with added triple inhaled therapy while in MATINEE, Nucala also lowered COPD exacerbations requiring ED visits &/or hospitalization (2EP); MATINEE & METREX data were published in The NEJM

Ref: GSK| Image: GSK| Press Release

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