GSK Announces NMPA Approval of Mepolizumab for Chronic Obstructive Pulmonary Disease in China

On December 22, GSK China announced that the National Medical Products Administration (NMPA) of China had approved Nucala® (mepolizumab injection) forAdult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophilsMaintenance treatment. Mepolizumab Injection isA biologic administered once monthly for the treatment of widespread COPD patients with blood eosinophil count (BEC) ≥150 cells/μL.。

This approval was based on the positive data from the Phase 3 clinical trials MATINEE and METREX. In these two trials,Mepolizumab significantly reduced the annual rate of moderate to severe exacerbations in a broad eosinophilic phenotype COPD population compared to placebo plus standard of care, with both clinical and statistical significance.The incidence of adverse events was similar in the placebo group and the mepolizumab group.

COPD is a progressive, heterogeneous inflammatory lung disease, including chronic bronchitis and/or emphysema. Despite triple inhaled therapy, many patients still experience persistent symptoms and disease exacerbation. Acute exacerbation refers to an event of acute worsening of COPD symptoms, which can lead to hospitalization and irreversible lung damage. Early intervention is crucial for preventing acute exacerbations and cumulative lung injury.

According to public reports, 67% of COPD patients who continue to experience acute exacerbations despite receiving inhaled triple therapy have a BEC greater than 150 cells/μL. Repeated acute exacerbations can accelerate disease progression, thereby increasing hospitalization rates, readmission rates, patient mortality, and the burden on the healthcare system.

Mepolizumab is a monoclonal antibody that specifically targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. This product has been developed for the treatment of a range of IL-5-mediated diseases associated with type 2 inflammation.

In the MATINEE and METREX trials, for patients with the eosinophilic phenotype, mepolizumab was added to the standard triple inhaled therapy.Compared with placebo, it can significantly reduce the annual incidence of moderate to severe acute exacerbations.[MATINEE: Rate ratio 0.79, 95% Confidence Interval [CI] 0.66, 0.94, p=0.01] (Mepolizumab group AER=0.80 exacerbations per year vs Placebo group=1.01 exacerbations per year) [METREX: Rate ratio 0.82, 95% CI 0.68, 0.98, adjusted p=0.04] (Mepolizumab group AER=1.40 exacerbations per year vs Placebo group=1.71 exacerbations per year). In the pre-specified secondary endpoints of MATINEE,The annual rate of acute exacerbations leading to emergency department visits and/or hospitalizations was lower in the mepolizumab group than in the placebo group.[Rate ratio 0.65, 95% CI (0.43-0.96) with nominal significance after multiplicity adjustment] (Mepolizumab group AER = 0.13 exacerbations per year vs placebo group = 0.20 exacerbations per year).

In addition, Mepolizumab Injection has been approved in China for maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above, as well as for the treatment of adults with inadequately controlled chronic rhinosinusitis with nasal polyps and adults with eosinophilic granulomatosis with polyangiitis. Currently, the drug has been approved in the United States for the treatment of COPD. Regulatory approvals worldwide are ongoing, including in Europe [the drug recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the COPD indication].

References:
[1]Nucala® (Mepolizumab Injection) Approved in China for the Treatment of Adult Chronic Obstructive Pulmonary Disease (COPD). From https://mp.weixin.qq.com/s/2sKiDsi_HKmNVCBOzfuAdw

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