• 26 May 2025
• Admin
• News Article

FDA Approves GSK’s Nucala for COPD Patients with Eosinophilic Phenotype

GSK plc has announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) who have an eosinophilic phenotype.

This marks a major step in addressing the needs of COPD patients at high risk of exacerbations despite optimized inhaled therapy.

Clinical Evidence Supporting Approval

The approval is based on positive data from the MATINEE and METREX trials, which demonstrated:

• Statistically significant reduction in the annualised rate of moderate/severe exacerbations vs. placebo
• Efficacy in a broad COPD patient population with eosinophilic inflammation
• Comparable safety profile between mepolizumab and placebo groups

METREX Trial

• Rate ratio: 0.82
• Confidence interval (CI): 0.68–0.98
• Adjusted P value: 0.04

MATINEE Trial

• Rate ratio: 0.79
• CI: 0.66–0.94
• P value: 0.01
• Reduction in hospital and ED-related exacerbations (not statistically significant):
  • RR: 0.65
  • CI: 0.43–0.96

Addressing a Major Healthcare Challenge

• Lead to irreversible lung damage
• Cause worsening of symptoms and increased mortality
• Result in emergency visits, hospital admissions, and significant healthcare costs

“The approval of Nucala provides an important option for COPD patients… Today there is hope for improved care,”

said Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK.

Targeting the Right Patient Population

• A simple blood test determines BEC, a marker for type 2 inflammation
• Mepolizumab is the only approved biologic shown effective in patients with BEC ≥150 cells/μL

High Unmet Need

• ~70% of COPD patients in the US on triple therapy with persistent symptoms have BEC ≥150 cells/μL
• This group represents over 1 million people eligible for biologic add-on therapy

Trial Designs and Patient Profiles

MATINEE Trial

• Duration: 52–104 weeks
• 804 patients with moderate to very severe COPD (GOLD stages 2–4)
• Enrolled patients with:
  • Chronic bronchitis
  • Emphysema
  • Combination of both
• All had previous exacerbations despite optimal inhaled therapy

METREX Trial

• Duration: 52 weeks
• 836 patients randomized (1:1)
• Included both:
  • Eosinophilic phenotype (BEC ≥150 cells/µL or ≥300 cells/µL in past year)
  • Non-eosinophilic phenotype (<150 cells/µL with no history of ≥300 cells/µL)

Expert Voices on the Impact

“Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”

– Dr. Jean Wright, CEO, COPD Foundation

Nucala: A Targeted Biologic Against IL-5

Nucala (mepolizumab) is a monoclonal antibody that targets interleukin-5 (IL-5), a key cytokine in type 2 inflammation. It:

• Reduces eosinophil levels
• Helps prevent inflammation-driven exacerbations
• Offers new hope for patients with limited treatment response to inhaled therapies

Currently, Nucala is:

• Approved in the US for 5 IL-5 mediated conditions
• Approved in Europe for 4 IL-5 mediated diseases

What’s Next?

• Submissions under review in China and Europe
• Nucala is not yet approved for COPD outside the United States

GSK’s Broader Vision in Respiratory Health

GSK continues to lead innovation in respiratory care with a robust portfolio and pipeline including:

• Targeted biologics
• Advanced inhaled medications
• Vaccines
• Novel treatments for refractory chronic cough and systemic sclerosis with interstitial lung disease

GSK’s mission:

To redefine respiratory medicine and improve outcomes for hundreds of millions affected by chronic lung diseases globally.