GSK’s Nucala Approved for Treating Chronic Rhinosinusitis with Nasal Polyps
Friday, January 03, 2025
GSK has announced that Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), has received approval from China’s National Medical Products Administration.
CRSwNP, a condition caused by persistent inflammation of the nasal lining, leads to the formation of soft tissue growths known as nasal polyps.
Symptoms include nasal obstruction, facial pressure, sleep disturbances, loss of smell, and nasal discharge, all of which can significantly impact patients' quality of life. Type 2 inflammation, which is characterised by high levels of IL-5, underpins most cases and contributes to polyp recurrence, even after surgical removal.
The treatment is intended for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who do not achieve sufficient disease control with systemic corticosteroids or surgery.
In China, it is estimated that approximately 107 million people suffer from chronic sinusitis, with a third of these individuals also experiencing nasal polyps.
The approval of Nucala is supported by evidence from two key studies.
The phase III MERIT trial, conducted among patients from China, Japan, and Russia, evaluated the treatment over 52 weeks and demonstrated significant improvements in nasal obstruction scores and patient-reported quality of life.
Additional data from the global SYNAPSE study further validated its efficacy.
Mepolizumab, which inhibits IL-5 to address type 2 inflammation, is already approved in China for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.
Its use as an add-on therapy with intranasal corticosteroids offers a non-surgical treatment option for CRSwNP patients, reducing the need for repeated systemic corticosteroid exposure.
The MERIT trial confirmed the safety and tolerability of mepolizumab, aligning with its established profile. Common adverse events were reported at similar rates in both treatment and placebo groups, with no severe treatment-related adverse events identified.
Originally approved in 2015 for severe eosinophilic asthma in the US, Nucala continues to demonstrate potential in treating diseases driven by type 2 inflammation.
Source: gsk.com
