By Fineline Cube 
UK biopharma GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Nucala (mepolizumab) as add‑on maintenance therapy for uncontrolled COPD in adults with raised blood eosinophils on triple therapy (ICS/LABA/LAMA). The drug was approved for COPD in the US in May 2025.
Regulatory Milestone
| Item | Details |
|---|---|
| Recommendation Date | 12 Dec 2025 |
| Regulatory Body | CHMP of the European Medicines Agency (EMA) |
| Product | Nucala (mepolizumab) |
| Indication | Add‑on maintenance therapy for uncontrolled COPD in eosinophilic adults on ICS/LABA/LAMA |
| Mechanism | IL‑5 monoclonal antibody |
| Current EU Approvals | 4 indications: severe asthma, CRSwNP, EGPA, HES |
| Expected EU Approval | Q1 2026 (EC decision) |
Clinical & Market Context
- COPD Prevalence: 30‑40 million adults in EU; ~20‑30% have eosinophilic phenotype (eligible for Nucala)
- Differentiation: First IL‑5 inhibitor for COPD in EU; targets type 2 inflammation vs. standard bronchodilators
- Competitive Landscape: Competes with Dupixent (IL‑4/13) in eosinophilic COPD; Nucala’s once‑monthly dosing offers convenience
- Peak EU Sales: Estimated €800‑1.2 billion (≈ US$850‑1.3 B) by 2030 if approved across eosinophilic COPD segment
Strategic Implications
- For GSK: Fifth indication for Nucala globally; strengthens respiratory franchise; offsets Advair/Seretide erosion; builds on US COPD approval momentum.
- For COPD Treatment: Provides targeted biologic option for eosinophilic patients inadequately controlled on triple therapy; reduces exacerbations and oral steroid dependence.
- For IL‑5 Class: Expands utility beyond asthma into COPD, competing directly with IL‑4/13 inhibitors; positions Nucala as broad type 2 inflammation therapy.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the EC approval timeline, market penetration, and competitive positioning. Actual results may differ due to regulatory feedback, payer negotiations, or competitive responses.-Fineline Info & Tech