GSK Scores FDA Approval for Nucala as Add-On Treatment to Reduce COPD Exacerbations

The FDA has approved GlaxoSmithKline’s (GSK) mepolizumab (Nucala) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The approval is supported by results from the phase 3 MATINEE (NCT04133909) and METREX (NCT02105948) trials, which demonstrated a reduction in the annualized rates of moderate or severe exacerbations associated with mepolizumab treatment. Following an unexpected delay earlier this month, the company has now received FDA authorization to advance its strategy.

Results support mepolizumab as the only approved biologic for COPD patients with blood eosinophil counts starting at 150 cells/μL

The approval was based on positive results from the phase 3 MATINEE and METREX trials. These studies showed that mepolizumab significantly reduced the annualized rate of moderate to severe exacerbations compared to placebo in a broad patient population. Preventing exacerbations is a critical aspect of COPD management, as these events can lead to irreversible lung damage, worsening symptoms, and increased mortality. The safety profile of mepolizumab was comparable to that of placebo across the trials.

Currently, mepolizumab stands as the only approved biologic for COPD that researchers have evaluated in patients with a blood eosinophil count (BEC) as low as ≥150 cells/µL. Clinicians use BEC, measured through a simple blood test, as a biomarker for type 2 inflammation to assess a patient’s risk of exacerbation. This makes BEC a valuable tool for identifying patients who may benefit from targeted biologic therapy, such as mepolizumab.

In the United States, approximately 70% of COPD patients who remain inadequately controlled despite inhaled triple therapy have a BEC of 150 cells/μL or higher. This subgroup represents over one million individuals at heightened risk of exacerbations that may result in emergency department visits or hospitalizations. For these patients, adding mepolizumab to their existing treatment regimen may offer a new option to reduce exacerbation risk and improve disease control.

“The approval of Nucala in the US provides an important option for COPD patients. Long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk, with particularly poor outcomes in those requiring hospital visits or admissions. Today there is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as ≥150cells/μL who need new options like Nucala to support their treatment journey,” stated Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK.

COPD hospitalizations cost the U.S. healthcare system $7 billion annually

In the phase 3 clinical trials, mepolizumab significantly reduced the annualized rate of moderate or severe exacerbations in patients with an eosinophilic phenotype when added to triple inhaled therapy. In MATINEE, the rate ratio (RR) was 0.79, and in METREX, the RR was 0.82. A pre-defined secondary endpoint in MATINEE also showed a reduced annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalization in the mepolizumab group (RR: 0.65; 95% CI: 0.43 to 0.96), though this result was not statistically significant due to the hierarchical testing strategy. 

Healthcare systems continue to shoulder a major burden from COPD hospitalizations, which experts project will become the leading cause of medical admissions. In the U.S. alone, emergency visits and inpatient care for COPD contribute to approximately $7 billion in annual direct medical costs. Currently, regulatory authorities outside the United States have not approved mepolizumab for COPD treatment. Regulatory submissions for approval are under review in both China and Europe.

COPD is a progressive and heterogeneous inflammatory lung condition that affects over 390 million people worldwide. It includes diseases such as chronic bronchitis and emphysema and features persistent symptoms like breathlessness, chronic cough, and sputum production. These symptoms result from ongoing inflammation and progressive airflow obstruction, significantly impairing patients’ quality of life and highlighting the ongoing need for improved treatment options.

While inhaled triple therapy remains the standard of care, many patients continue to experience persistent symptoms or acute exacerbations. These exacerbations can lead to hospitalizations, irreversible lung damage, and increased mortality, particularly in more severe cases. As a result, there is a critical demand for therapies that address the underlying inflammation and reduce the risk of exacerbations in this population. Jean Wright, MD, MBA, Chief Executive Officer of the COPD Foundation said, “COPD isn’t just a disease, it’s a relentless cycle. For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”

Related posts:

GSK’s Penmenvy Secures FDA Approval to Combat Five Major Meningococcal Serogroups Among Youth FDA Greenlights Soleno Therapeutics’ VYKAT XR for PWS Hyperphagia BridgeBio Bags First FDA Nod with Rare Disease Drug Acquired from Alexion Biogen’s Controversial Alzheimer’s Drug Wins Historic FDA Approval

Author

Denisse Sandoval