GSK Announces FDA Approval of Nucala (Mepolizumab) as First IL-5 Inhibitor for COPD with Eosinophilic Phenotype
GSK
Pharmaceutical R&D Manufacturer
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The FDA approval was based on positive data from the MATINEE and METREX Phase III trials. In these trials, compared with placebo,Mepolizumab significantly reduces the annual rate of moderate/severe exacerbations in patients with chronic obstructive pulmonary disease across various eosinophilic phenotypes, with both clinical and statistical significance.。The primary endpoint of the study was the annual exacerbation rate of moderate to severe COPD. Exacerbations are devastating for patients, known to cause irreversible lung damage, worsening symptoms, and increased mortality. The incidence of adverse events was similar between the placebo group and the mepolizumab group.
The results showed,After 104 weeks of treatment,The annual exacerbation rate in the mepolizumab group was significantly lower than that in the placebo group (0.80 vs 1.01, P=0.01).。
Mepolizumab (Mepolizumab) is a humanized monoclonal antibody against IL-5, which inhibits IL-5-mediated inflammatory responses by blocking the interaction between IL-5 and the surface receptors on eosinophils. The drug was first approved by the FDA for marketing in November 2015. Previously, the indications approved globally included:Add-on maintenance treatment for severe asthma with eosinophilic phenotype in patients aged 6 years and above, add-on maintenance treatment for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to intranasal corticosteroids, adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES) in patients aged 12 years and above.
In China, Mepolizumab was approved for marketing by the NMPA in 2021 and has now been covered.Eosinophilic Granulomatosis with Polyangiitis, Severe Eosinophilic Asthma, and Chronic Rhinosinusitis with Nasal PolypsThree indications, becoming an important targeted treatment option for Type 2 inflammation-related diseases.
IL-5TargetProgress in Points and Drugs
IL-5Is byA cytokine produced by various cell types, primarily secreted by T cells, and playing a crucial role in promoting the growth and differentiation of B cells and eosinophils.
These targeted drugs work by specifically binding to IL-5 or its receptor, thereby blocking its signaling pathway and inhibiting the proliferation and activation of eosinophils. These drugs can significantly reduce the number of eosinophils in the blood, alleviating symptoms associated with related diseases. At the same time, they can also improve airway inflammation and respiratory function, thus enhancing the quality of life for patients.
Mepolizumab is a key product of GSK. The drugApproved for marketing in the U.S. in November 2015, its sales have been increasing year by year. In 2024, the drug's sales reached $2.279 billion, a year-on-year increase of 10%.
Source: Insight Database
With the expansion of new indications, the sales of Mepolizumab are expected to grow further.
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