FDA Approves Nucala as Maintenance Therapy for COPD

The FDA has approved GSK’s Nucala (mepolizumab) as an add-on maintenance therapy for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype.

COPD is a progressive inflammatory lung disease that includes chronic bronchitis and/or emphysema. It affects more than 390 million people globally and is the third leading cause of death. COPD can cause progressive airflow obstruction.

A subset of patients with COPD also have an increase in blood eosinophils, a type of white blood cell that is a biomarker for inflammation. Previous research has shown that COPD with an increase in blood eosinophil count (BEC) is a distinct type of COPD with a specific pattern of airway inflammation.

“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,” Jean Wright, M.D., MBA, CEO of the COPD Foundation, said in a news release.

The FDA’s approval of Nucala in COPD was based on data from the MATINEE and METREX phase 3 trials. These trials assessed Nucala 100 mg as add-on therapy, administered subcutaneously every four weeks compared with placebo in addition to inhaled triple therapy, which included dual long-acting bronchodilators plus inhaled corticosteroid.

In both trials, Nucala demonstrated a statistically significant reduction in the annualized rate of moderate or severe exacerbations compared with placebo when added to triple inhaled therapy. In a predefined secondary endpoint in MATINEE, the annualized rate of COPD exacerbations requiring emergency room visits and/or hospitalization was reduced in the Nucala group.

The MATINEE study assessed the efficacy and safety of Nucala for 52 to 104 weeks in patients with COPD with a blood eosinophil count of ≥300 cells/µL. (The normal range for eosinophil count is between 30 and 350 cells per microliter of blood.)

The full analysis, published April 30, 2025, in the New England Journal of Medicine, included 403 patients enrolled in the Nucala arm and 401 on placebo, all of whom had experienced exacerbations in the previous year despite receiving optimized inhaled maintenance therapy.

In METREX, the efficacy and safety of Nucala were evaluated for 52 weeks in 836 patients randomized to mepolizumab or placebo. This study was published in 2017 in the New England Journal of Medicine.

Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. It is also approved in the United States for four other inflammatory indications, including severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

The list price for a single dose of Nucala for self-injection is $3,799.49.

GSK offers a bridge program for patients waiting for prior authorization to access free doses of Nucala, as well as a $0 copay support program that offers different levels of support depending on a patient’s health plan. For commercially insured patients whose plans count the assistance toward out-of-pocket maximums, annual maximum support for Nucula is $9,450 annually. For patients with high-deductible health plans that credit the amount of the GSK copay program toward their plan out-of-pocket responsibilities, the maximum copay support is up to $15,000 annually.

Effective Jan 1, 2025, the copay maximum for patients who are enrolled in maximizer plans is $5,000 annually. A maximizer plan is an insurance plan that sets an individual’s cost-sharing amount at the maximum value of the manufacturer’s copay assistance and do not credit the amount toward the patient’s deductible and annual out-of-pocket maximums.