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GSK Secures Approval From Chinese NMPA for Nucala, its Add-On-Therapy to Treat CRSwNP
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GSK has received approval from the China National Medical Products Administration (NMPA) for Nucala (mepolizumab) to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. The drug serves as an add-on therapy alongside intranasal corticosteroids. This marks the third indication in China for Nucala, a monoclonal antibody targeting interleukin-5 (IL-5), used to address IL-5-mediated conditions. The approval offers an alternative treatment for patients who have not achieved sufficient relief from systemic corticosteroids or surgical procedures.
Mepolizumab Demonstrated Significant Improvement in Nasal Obstruction and Quality of Life in Phase III MERIT Trial
The approval of Nucala (mepolizumab) for chronic rhinosinusitis with nasal polyps (CRSwNP) is based on the phase III MERIT trial, which assessed the drug’s efficacy and safety over a 52-week period. The trial involved patients from Japan, China, and Russia with inadequately controlled CRSwNP and compared mepolizumab to a placebo. Additionally, the approval is supported by data from the global phase III SYNAPSE study, which explored mepolizumab’s effects versus a placebo in over 400 CRSwNP patients. In China, authorities have already approved mepolizumab as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe eosinophilic asthma and for adults with eosinophilic granulomatosis with polyangiitis.
The MERIT trial included a total of 163 participants, 80 receiving mepolizumab and 83 receiving placebo. Results showed that mepolizumab significantly improved the nasal obstruction visual analogue scale (VAS) score and led to a numerical reduction in nasal polyp score at week 52. The trial also measured improvements in patient quality of life using the 22-item Sino-Nasal Outcome Test (SNOT-22), where mepolizumab demonstrated a significant difference from placebo at Week 52.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK said, “We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed. Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids.”
80% of CRSwNP Patients Exhibit IL-5 Driven Type 2 Inflammation Linked to Severe Disease
Approximately 107 million people in China are estimated to suffer from chronic sinusitis, with about one-third of these individuals experiencing CRSwNP. Patients with CRSwNP often face symptoms including nasal obstruction, loss of smell, facial pressure, sleep disturbances, and nasal discharge. These symptoms can severely impact both their physical and emotional well-being.
CRSwNP results from chronic inflammation of the nasal lining, leading to the growth of nasal polyps in the sinuses and nasal cavity. Type 2 inflammation, a key factor in up to 80% of cases, is linked to severe disease and frequent recurrence of polyps. While surgery remains a common option for removing polyps, the underlying inflammation often causes regrowth, making long-term management a challenge.
Globally, various treatment options are available for CRSwNP. Besides surgical interventions, oral corticosteroids are commonly used for short-term relief during flare-ups, though long-term use is limited due to side effects. Intranasal corticosteroid sprays offer localized relief and are widely prescribed. In the biologics space, therapies such as dupilumab (Dupixent), omalizumab (Xolair), and mepolizumab (Nucala) target pathways associated with type 2 inflammation, providing alternatives for patients with severe or recurrent cases. Nevertheless, the availability and use of these treatments vary by region.
