GSK has received China’s National Medical Products Administration (NMPA) approval for Nucala (mepolizumab) to treat adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
Nucala is a monoclonal antibody that targets interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation, first approved in 2015 to treat severe asthma.
The drug is indicated as add-on therapy with intranasal corticosteroids to treat adult patients with CRSwNP for whom corticosteroids or surgery is adequate for disease control.
According to GSK, people with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge.
CRSwNP is caused by chronic inflammation of the nasal lining that can cause soft tissue growth, known as nasal polyps, that develop in the sinuses and nasal cavity.
GSK SVP and respiratory/immunology R&D global head Kaivan Khavandi 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.”
The NMPA approval is based on results from the MERIT trial, a randomised, double-blind, placebo-controlled, parallel-group, Phase 3 study in Japan, Russia, and China.
MERIT evaluated the efficacy and safety of Nucala in patients with chronic rhinosinusitis with nasal polyps (CRSwNP)/eosinophilic CRS (ECRS) compared to placebo.
The approval is also supported by data from the global Phase 3 SYNAPSE study, which explored the effect of Nucala compared to placebo in over 400 patients with CRSwNP.
The drug is already approved in China to treat severe eosinophilic asthma in adults and adolescents above 12 years, and eosinophilic granulomatosis with polyangiitis in adults.
In the studies, the treatment with Nucala significantly improved nasal obstruction VAS score and resulted in the reduction of nasal polyp score in 163 participants.
Nucala showed improvements in patient quality of life, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22) Week 52 and loss of smell VAS score at Weeks 49-52.
Furthermore, Nucala showed safety and tolerability data that were consistent with the known profile of the drug, with no severe adverse events.
