US EditionFDA Approves Nucala for Chronic Obstructive Pulmonary Disease
- On May 23, 2025, the FDA authorized the use of Nucala as a supplementary maintenance therapy for adults in the US whose chronic obstructive pulmonary disease remains inadequately managed.
- This approval followed the phase 3 MATINEE and METREX trials that tested Nucala 100 mg subcutaneously every four weeks alongside triple inhaled therapy.
- The MATINEE trial enrolled 804 patients with blood eosinophil counts of at least 300 cells/μL and demonstrated that adding Nucala to triple inhaled therapy significantly lowered the yearly rate of moderate to severe COPD flare-ups compared to placebo by 21%.
- In METREX, patients on Nucala experienced 1.40 exacerbations per year versus 1.71 for placebo, with a rate ratio of 0.82; adverse events were comparable between groups.
- These results suggest Nucala offers a new option for about 70% of US COPD patients with BEC ≥150 cells/μL who remain uncontrolled despite triple therapy and face exacerbations.
77 Articles
77 Articles
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).
Cleared for Breath, Clouded in Doubt: The Political Economy Behind the FDA’s Approval of Nucala for COPD
Hope often comes with a disclaimer. That was the unspoken sentiment last week when the U.S. Food and Drug Administration (FDA) approved the biologic drug Nucala (mepolizumab) for use in treating a subset of patients with chronic obstructive pulmonary disease (COPD). Heralded by its manufacturer, GSK, as a breakthrough for those suffering from eosinophilic inflammation—a rare but hard-to-treat form of COPD—the approval was widely reported as a wi…
FDA Approves GSK’s Nucala for COPD Patients with Eosinophilic Phenotype
PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This marks a major milestone, offering a new treatment option for individuals whose condition remains inadequately controlled despite inhaled triple therapy. Nucala is the first and only biologic approved for a…
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