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Highlights
- GSK's Nucala (mepolizumab) has been approved by China's National Medical Products Administration for CRSwNP treatment.
- The approval follows positive results from Phase III trials, demonstrating its efficacy in patients with inadequately controlled disease.
- Nucala is already approved in China for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.
GSK plc (LSE:GSK) has announced that its monoclonal antibody, Nucala (mepolizumab), has been approved by the China National Medical Products Administration (NMPA) as an add-on therapy for adult patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). Nucala will be used alongside intranasal corticosteroids to treat patients for whom systemic corticosteroids and/or surgery have not provided adequate disease control.
CRSwNP is a condition characterized by chronic inflammation of the nasal lining, leading to the growth of nasal polyps in the sinuses and nasal cavity. It is estimated that approximately 107 million people in China suffer from chronic sinusitis, with about one-third of these individuals affected by CRSwNP. Symptoms of CRSwNP, such as nasal obstruction, loss of smell, facial pressure, sleep disturbances, and nasal discharge, can significantly impact both physical and emotional well-being.
The approval of Nucala is based on the positive results of the Phase III MERIT trial, which studied the efficacy and safety of mepolizumab in a population of patients from China, Japan, and Russia. This trial showed promising results for patients with inadequately controlled CRSwNP, further supported by the global Phase III SYNAPSE study, which demonstrated the drug's effectiveness in more than 400 patients.
Mepolizumab targets interleukin-5 (IL-5), a cytokine that plays a crucial role in type 2 inflammation, which is often present in patients with CRSwNP. This inflammation is a major driver of nasal polyp formation and recurrence. By targeting IL-5, Nucala helps reduce the underlying inflammation and can lead to better disease management, even in cases where surgery alone is not sufficient.
In addition to its new indication for CRSwNP, Nucala is already approved in China as a treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older, as well as for eosinophilic granulomatosis with polyangiitis in adults.
