GSK Secures EU Nod for Nucala in COPD, £2 Billion 2025 Sales Highlight
GSK secured European Commission approval for Nucala as an add-on maintenance treatment in COPD patients with elevated blood eosinophils, marking the first monthly biologic indication in the EU. Nucala generated £2.01 billion in 2025 sales after a 15% y/y rise, intensifying competition in respiratory biologics.
1. EU Approval of Nucala for COPD
The European Commission granted approval for Nucala (mepolizumab) as an add-on maintenance therapy for adults with uncontrolled COPD and elevated eosinophil counts, following a positive EMA opinion in December 2025. This expands Nucala’s indications to include COPD in the EU, leveraging its prior FDA clearance in May 2025 as the first monthly biologic for eosinophilic COPD.
2. Nucala’s Commercial Performance
Nucala achieved £2.01 billion in global sales during 2025, up 15% year over year on a constant-currency basis. The approval was driven by phase III MATINEE study results showing significant reductions in moderate/severe exacerbation rates, emergency department visits and hospitalizations.
3. Competitive Implications for Immunocore
The expanded use of Nucala underscores intensifying competition in respiratory biologics, a space where Immunocore is developing pipeline assets. Strong sales momentum and broadening indications for Nucala may pressure Immunocore’s valuation and market share prospects in respiratory immunotherapies.