FDA Approves Nucala for Chronic Obstructive Pulmonary Disease

FDA Approves Nucala for Chronic Obstructive Pulmonary Disease

FRIDAY, May 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD).

FDA Approves Nucala as Maintenance Therapy for COPD

Nucula’s new indication is as an add-on therapy for patients with COPD who also have an elevated blood eosinophil count.

FDA approves GSK's Nucala to treat COPD

GSK has received approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab).

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

FDA approves GSK’s Nucala for COPD with eosinophilic phenotype, backed by trial data showing reduced exacerbations rates in adults.

GSK Plc Nucala approved by FDA for Eosinophilic COPD

GSK plc (LON/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. ·   Nucala is the only approved biologic studied in a wide COPD population with an eosinophilic phenotype characterised by blood eosinophil count (BEC) starting at 150 cells/μL  ·   Approval based on the positiv…

FDA Approves Mepolizumab for Treatment of COPD Exacerbations

Approval comes from positive results in the MATINEE and METREX phase III trials, with data showing a significant reduction in annual rates of COPD exacerbations among patients.