• 09 Feb 2026
• Admin
• News Article

EU Approves GSK’s Nucala for Eosinophilic COPD

GSK plc has secured European Commission approval for Nucala (mepolizumab) as an add-on maintenance therapy for adults with uncontrolled COPD marked by elevated blood eosinophils. The approval applies to patients already receiving inhaled triple therapy:

• Inhaled corticosteroid (ICS)
• Long-acting beta₂-agonist (LABA)
• Long-acting muscarinic antagonist (LAMA)

Why This Approval Is a Big Deal?

COPD remains one of the deadliest chronic diseases worldwide.

• Affects 390+ million people globally
• Around 40 million patients in Europe
• Third leading cause of death worldwide
• One in ten hospitalised patients die during admission
• Half die within five years after hospitalisation

Despite triple inhaled therapy, many patients continue to experience frequent exacerbations

MATINEE Trial: The Data Behind the Decision

Approval is based on the Phase III MATINEE trial, which evaluated mepolizumab in COPD patients with a type 2 inflammatory phenotype.

Key Efficacy Results

• 21% reduction in annualised moderate or severe exacerbations
  • Rate ratio: 0.79
  • P value: 0.01
• Annualised exacerbation rate:
  • 0.80 with mepolizumab
  • 1.01 with placebo

Hospitalisation and ED Visits

• 35% reduction in exacerbations requiring:
  • Emergency department visits
  • Hospitalisation
• Rate ratio: 0.65
• Nominally significant after multiplicity adjustment

Nucala is the first biologic to show Phase III evidence reducing exacerbations leading to hospitalisation in COPD.

Safety Profile

• Adverse events were comparable to placebo
• Incidence:
  • Mepolizumab: 74%
  • Placebo: 77%

No new safety signals were reported.

Who Was Studied in MATINEE?

The trial enrolled a broad COPD population, including patients with:

• Chronic bronchitis
• Emphysema
• Mixed disease phenotypes

All participants had:

• Blood eosinophils ≥300 cells/µL
• At least one exacerbation in the prior year
• Optimised inhaled triple therapy

Total patients:

• 403 on mepolizumab
• 401 on placebo

What Nucala Adds to COPD Treatment?

Nucala targets interleukin-5 (IL-5), reducing eosinophil-driven inflammation. For eligible patients, it offers:

• Once-monthly subcutaneous dosing
• Reduced exacerbation burden
• Potential prevention of irreversible lung damage

“For the first time, adults with uncontrolled eosinophilic COPD in the EU will have access to a monthly biologic shown to reduce exacerbations.”

• — Kaivan Khavandi, SVP, GSK

Existing Nucala Footprint

Nucala is already approved in Europe for:

• Severe asthma
• CRSwNP
• EGPA
• Hypereosinophilic syndrome

COPD approvals are already in place in:

• US
• UK
• China

Strategic Takeaway

This approval signals a shift in COPD management:

• From symptom control
• To phenotype-driven biologic intervention

For GSK, it reinforces leadership in respiratory biologics. For patients, it finally opens the door beyond inhalers.