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Mepolizumab Approved for Eosinophilic COPD | New Biologic Therapy - News Directory 3

Mepolizumab Approved for Eosinophilic COPD | New Biologic Therapy

June 30, 2025 Health
News Context
At a glance
  • The FDA has approved mepolizumab ⁢(Nucala, GSK) for chronic obstructive pulmonary disease, specifically for patients with an‍ eosinophilic ⁣phenotype.
  • Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation research and development at GSK, discussed the current COPD standard of care, mepolizumab's role and...
  • Current inhaled therapies offer symptom relief and ⁤can lower exacerbation rates, Khavandi said.
Original source: healio.com

The FDA has greenlit mepolizumab (Nucala) as a ‍new treatment for chronic obstructive pulmonary ⁤disease (COPD) patients exhibiting an eosinophilic phenotype. This groundbreaking decision ⁤stems from positive findings⁣ in the MATINEE and METREX trials,signaling a ⁢major step forward. Mepolizumab offers a novel approach by targeting type 2 inflammation,aiming to substantially reduce ⁤exacerbations. Learn ⁢how mepolizumab could improve outcomes for nearly 70% of COPD patients⁢ inadequately controlled by current therapies. News Directory 3 is tracking the latest respiratory breakthroughs. Discover ⁣the potential of this new biologic therapy in treating COPD⁤ and what this means for patients. Discover what’s next in respiratory medicine.

Key Points

  • Mepolizumab (Nucala) is now FDA-approved for COPD with an eosinophilic phenotype.
  • The approval is based on the MATINEE and METREX trials.
  • Mepolizumab aims to reduce exacerbations in COPD patients.
  • The drug targets type 2 inflammation by reducing eosinophil levels.

Mepolizumab Approved for COPD With Eosinophilic Phenotype

⁤ Updated June 30, 2025

The FDA has approved mepolizumab ⁢(Nucala, GSK) for chronic obstructive pulmonary disease, specifically for patients with an‍ eosinophilic ⁣phenotype. The decision was partially informed by the MATINEE⁣ and ⁤METREX trials,⁢ according to GSK.

Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation research and development at GSK, discussed the current COPD standard of care, mepolizumab’s role and key trial findings.

Current inhaled therapies offer symptom relief and ⁤can lower exacerbation rates, Khavandi said. However, more than 40% of COPD patients still experience exacerbations, and about one in five require hospitalization.Of those hospitalized, 10% may die during their stay, and half may die within five years. Therefore, new methods to reduce exacerbations are vital.

Mepolizumab improves on‍ existing therapies ‍by targeting type 2 inflammation, khavandi said. roughly 70% of U.S. COPD patients inadequately controlled by inhaled therapies have a blood eosinophil count (BEC) of 150 cells/μL or higher. BEC, measured via ⁢a blood test, indicates a patient’s risk for exacerbation.

the MATINEE and ⁣METREX trials showed mepolizumab significantly reduced moderate or severe ⁢exacerbations compared to placebo when added to inhaled therapies in‍ COPD patients with an ⁢eosinophilic phenotype, including those with BEC starting ⁤at 150 cells/μL in ⁢METREX, Khavandi said.

Khavandi highlighted that ‍both trials included patients with and ⁢without chronic bronchitis, representing a wide⁢ spectrum of type 2 inflammation. The studies did not require patients to have chronic bronchitis and⁢ included those with very severe airflow obstruction.

MATINEE data also indicated a reduction in ⁣exacerbations leading to hospitalization or emergency⁣ department visits, though⁣ this was not statistically important, Khavandi noted.

Regarding safety, Khavandi said mepolizumab has a robust safety profile from phase ‍3 trials, supported by over a decade of physician experience across four other indications. The frequency of adverse⁢ events was similar between⁣ the mepolizumab and placebo groups in both MATINEE and‍ METREX.

Inhaled therapy – viewed as ⁣a standard of care ‍- provides symptom relief to patients and can also reduce exacerbation rate. However, more than 40% of patients with COPD continue to experience exacerbations.

Kaivan Khavandi

What’s next

Mepolizumab is already available‍ in the U.S. for other ⁤conditions,and health care providers can ⁣now ⁢prescribe it for COPD patients with an eosinophilic phenotype,Khavandi said. Regulatory submissions are underway globally, and GSK plans to⁢ continue advancing⁣ the science of IL-5 inhibition in respiratory diseases.

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