GSK's Mepolizumab Becomes First IL-5 Monoclonal Antibody Approved for Eosinophilic COPD
GSK
Pharmaceutical R&D Manufacturer
Local time on May 22,GlaxoSmithKline (GSK)Announced that the US FDA has approved its IL-5 monoclonal antibodyMepolizumab(Nucala) New Indication Approved for Eosinophilic TypeAdjuvant Maintenance Therapy for COPD Patients。
Mepolizumab is the world's first approved IL-5 monoclonal antibody., as well as the world's first approved biologic that can be administered once a month for the treatment of COPD patients, representing a breakthrough in COPD treatment.
COPD is a progressive, heterogeneous inflammatory lung disease, including chronic bronchitis and emphysema. Globally, more than 390 million people suffer from COPD, indicating a significant clinical demand. Among them,China has approximately 100 million patients, the United States has more than 14 million patients, and Europe has more than 40 million patients.。
COPD patients experience persistent respiratory symptoms such as shortness of breath, coughing, and sputum production, as well as progressive airflow obstruction caused by chronic inflammation, affecting daily life. Relevant statistics show,COPD is the third leading cause of death globally, resulting in over 3 million deaths each year.。
The study found that,IL-5 is a key cytokine in type 2 inflammation, playing an important role in the growth, activity, and survival of eosinophils, and having a broad impact on other immune and structural cell types beyond eosinophils, including those cells that lead to inflammation, lung remodeling, and disease progression. Therefore, IL-5 targeted drugs also have the potential to treat COPD.
Results from the Phase III, randomized, double-blind, parallel, placebo-controlled trial MATINEE (NCT04133909) showed:
Compared with the placebo group, the annualized rate of moderate/severe disease exacerbations in patients treated with Mepolizumab was reduced by 21%, which was clinically meaningful and statistically significant, achieving the primary endpoint of the study.
In a post-hoc analysis of patients clinically assessed as having chronic bronchitis, the annualized rate of moderate/severe exacerbations in the mepolizumab group was reduced by 31% compared to the placebo group.
Reducing hospitalizations is a key goal in COPD management. In the study, mepolizumab reduced the annual rate of disease exacerbations leading to emergency room visits and/or hospitalizations by 35%. GSK noted that mepolizumab is the only biologic shown in Phase III clinical trial data to reduce the number of emergency room visits and/or hospitalizations.
Patients in the mepolizumab group reported higher Patient-Reported Outcome (PRO) remission rates, but there were no significant differences between the mepolizumab group and the placebo group in quality of life scores such as the St. George's Respiratory Questionnaire (SGRQ) and the COPD Assessment Test (CAT).
The incidence of adverse events was similar between mepolizumab and placebo, with the most common being COPD exacerbation or worsening and COVID-19 infection.
The pathogenesis of COPD is complex, and its causes have not been fully elucidated. For more than a decade, no new drugs were introduced until the arrival of breakthrough targeted medications in 2024.
In 2024,Sanofi/Regeneron's IL-4R Monoclonal Antibody "Dupilumab"Approved successively in the EU, mainland China, and the United States, it has become the world's first approved COPD biotargeted drug, and also a trailblazer for biologics in the COPD field.
Another one is developed by Verona.New Chemical Drug Ensifentrine, it is the first new-mechanism inhaled drug approved for marketing in nearly 20 years. It was approved for the first time in the United States in June 2024 for maintenance treatment of COPD in adults. Ensifentrine is also the world's first dual-target PDE3/4 inhibitor, offering both bronchodilation and anti-inflammatory effects. Recently, the drug announced positive topline results from the ENHANCE-CHINA Phase III clinical trial for COPD conducted in China, with plans to submit a new drug application to the NMPA in the second half of 2025. Previously, the drug had been approved in Macao and introduced in Hainan Boao Lecheng Pilot Zone, accelerating its commercialization process in the Chinese market.
The successful launch and excellent commercial performance of Ensifentrine have broken the deadlock in COPD treatment and also initiated a wave of enthusiasm for PDE3/4 inhibitor research and development. Currently, several pharmaceutical companies in China have already laid out plans for PDE3/4 inhibitors, among which...Three products have entered the clinical stage: TQC3721 from Zhengda Tianqing, HSK39004 from Haisi Pharmaceuticals, and HRS-9821 from Hengrui Medicine.。
In the future, there may be more innovative drugs with new mechanisms coming to the market, bringing treatment hope to COPD patients.
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