May 22, 2025 – The U.S. Food and Drug Administration (FDA) has approved GSK’s Nucala (mepolizumab) for the treatment of chronic obstructive pulmonary disease. This approval expands Nucala’s indication as an add-on therapy for individuals with a specific form of COPD.
FDA’s approval of mepolizumab was based on positive results from the MATINEE and METREX trials. These trials showed a significant reduction in moderate to severe exacerbations in COPD patients with an eosinophilic phenotype compared to placebo.
Mepolizumab is the only approved biologic tested in patients with an eosinophilic phenotype, defined by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL. Its approval could make a significant impact on the COPD treatment market.
A large portion of COPD patients in the United States have a BEC starting at 150 cells/μL and above. For these patients, adding mepolizumab could be considered as an additional treatment option for their COPD.
According to Coherent Market Insights (CMI), the global chronic obstructive pulmonary disease (COPD) market size is forecast to expand from USD 20.35 Bn in 2025 to USD 30.41 Bn by 2032. Global demand for COPD treatments will likely increase at a CAGR of 5.9% through 2032.
Views and Statements
The prevalence of COPD, commonly known as ‘smoker’s lung’, continues to surge globally. As a result, this new approval will offer hope for millions of patients struggling with persistent symptoms and frequent exacerbations.
Kaivan Khavandi, SVP, Respiratory R&D, GSK, said, “Nucala’s approval in the United States offers an ideal option for COPD patients.” He further added, “Today, there is renewed hope for better care for COPD patients with an eosinophilic phenotype who require new treatment options like Nucala to enhance their treatment journey.”
Jean Wright, CEO of COPD Foundation stated, “COPD is not just a disease, but a persistent, unending cycle. For individuals living with COPD, managing exacerbations remains a constant struggle, despite using inhaled maintenance therapy. However, biologics like mepolizumab are bringing new hope to patients battling this condition.”
Impact and Future Outlook
FDA’s approval of Nucala marks a pivotal advancement in the treatment landscape for COPD treatments. It will offer a new ray of hope for patients with chronic obstructive pulmonary disorder (COPD).
Patients suffering from COPD often face exacerbations, prompting them to seek effective treatments. Nucala’s approval will offer a new, effective therapeutic option that potentially reduces moderate to severe exacerbations in COPD.
Nucala is a type of monoclonal antibody that specifically targets interleukin-5 (IL-5), a protein that plays a key role in the growth and activation of eosinophils. By blocking IL-5, Nucala helps to reduce the number and activity of eosinophils. This, in turn, decreases inflammation and helps lower the frequency of COPD exacerbations.
Mepolizumab is not currently approved for the treatment of COPD in any other country. Regulatory submissions are presently under review in both China and Europe. If approved, these approvals could pave the way for broader global access to mepolizumab.
New approval of Mepolizumab could potentially transform COPD management for patients with an eosinophilic phenotype worldwide. It will also encourage other pharmaceutical companies to invest rigorously in R&D to create novel treatments for COPD and other respiratory disease.
Sources:
News Outlet: Reuters
Company: GSK plc
