GSK Submits New Indication Application in China for Monthly Subcutaneous Anti-IL-5 Antibody Mepolizumab for COPD

Feb 11, 2025 09:32 CST Updated 09:32

GSK

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Today (February 11), the latest announcement on the official website of China's National Medical Products Administration (CDE) showed that GlaxoSmithKline (GSK) has applied for the classification of biological products 2.2.Anti-IL-5 monoclonal antibodyMepolizumabMarketing application for the injection accepted.According to the GSK official website and publicly available information, the indication for which Mepolizumab is being submitted for marketing approval in China this time may beChronic Obstructive Pulmonary Disease (COPD). For this indication, mepolizumab has not been approved globally.

Screenshot source:CDE Official Website

Interleukin-5 (IL-5) is a cytokine that regulates the growth, activation, and survival of eosinophils, and provides critical signals for the migration of eosinophils from the bone marrow to the lungs and other organs.

Public information shows that Mepolizumab is the world's first approved anti-IL-5 monoclonal antibody. It works by binding to IL-5, blocking IL-5 from binding to the surface receptor on eosinophils, inhibiting the biological activity of eosinophils and continuously reducing their numbers to normal levels, therebyReduce the growth of eosinophils, as well as the inflammation and tissue damage mediated by eosinophils, to maintain a healthy state.。

Mepolizumab has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.Globally, the indications for which the product has been approvedIncluding:For ages 6 and aboveSeverity of Eosinophilic PhenotypeAsthmaThe patient's additional maintenance treatment, asChronic Rhinosinusitis with Nasal Polyps (CRSwNP)Add-on maintenance treatment for adult patients with inadequate response to nasal corticosteroids;TreatmentEosinophilic Granulomatosis with Polyangiitis (EGPA)；For the treatment of individuals aged 12 years and aboveHypereosinophilic Syndrome (HES). However, for the COPD indication, the product has not yet been approved globally.

In China, Mepolizumab was first approved by the NMPA in 2021 and has since been granted three indications, includingEosinophilic Granulomatosis with Polyangiitis、Severe Eosinophilic Asthma、Chronic Rhinosinusitis with Nasal Polyps。

Image Source: 123RF

In December 2024, GSK announced that the FDA had accepted the new indication application for Mepolizumab.As an add-on maintenance treatment for patients with eosinophilic phenotype chronic obstructive pulmonary disease (COPD), PDUFA date is May 7, 2025.GSK's press release stated that if approved, mepolizumab could be the first drug approved for patients with chronic obstructive pulmonary disease.Monthly administrationBiological agents.

The FDA accepted the new indication application for mepolizumab based on data from the MATINEE study, which evaluated mepolizumab.Efficacy and safety in 804 COPD patients with evidence of type 2 inflammation characterized by blood eosinophil count.The MATINEE study investigates the addition ofMepolizumabReached its primary endpoint compared with placebo,In patients treated for 52-104 weeks, a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations was achieved.

According to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, GSK has also registered and conductedMATINEE Study, EvaluationMepolizumabEfficacy and Safety as an Adjunctive Therapy for Subjects with Eosinophilic-Related and Frequent Acute Exacerbations of COPD. The study has been completed. In this study,The administration method of Mepolizumab isSubcutaneous injection once every 4 weeks using a safety syringe (SS)。

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Feb 11, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps. Retrieved Jan 3, 2025, from https://www.gsk.com/en-gb/media/press-releases/gsk-s-nucala-mepolizumab-approved-in-china-for-treatment-of-adults-with-chronic-rhinosinusitis-with-nasal-polyps/

[3]US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD.Retrieved Dec 9, 2024, from https://www.gsk.com/en-gb/media/press-releases/us-fda-accepts-gsk-s-submission-for-the-use-of-nucala-mepolizumab-in-copd/

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