The approval was based on positive data from a Phase 3 trial in which patients who received Nucala experienced 65% fewer clinically significant exacerbations
GSK’s scientists working in a lab. (Credit: GSK plc)
GSK has received approval from the China National Medical Products Administration (NMPA) for Nucala (mepolizumab) to treat certain adults who have severe asthma with an eosinophilic phenotype.
Nucala is the first-in-class monoclonal antibody to target Interleukin 5 (IL-5). It was first approved in 2015 for severe asthma with an eosinophilic phenotype in the US.
China’s NMPA approved the antibody as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and more.
GSK R&D respiratory and immunology senior vice president and global head Kaivan Khavandi said: “We are delighted with this approval, supported by evidence in a Chinese population.
“Millions of people in China with severe eosinophilic asthma can now potentially benefit from the advance in management that Nucala could offer – a testament to GSK’s ongoing commitment to redefine respiratory disease management globally.”
The approval was based on positive data from a separate Phase 3 trial among Chinese patients.
The study’s findings support previous research on mepolizumab in patients with severe asthma.
GSK said that there were no newly identified safety concerns that were unique to Chinese patients, and adverse events were in line with the established safety profile for Nucala.
The 52-week late-stage study assessed the effect of mepolizumab against a placebo, as an add-on therapy. The trial, primary endpoint was a reduction in the annual rate of clinically significant exacerbations (CSE).
According to the results, the patients who were administered Nucala compared to those who received placebo experienced 65% fewer CSEs.
They also had a 70% reduction in the frequency of CSE per year requiring hospitalisation.
Additionally, the findings showed a significantly increased period before patients felt the first CSE requiring hospitalisation.
The approval represents the second indication in China. It was approved in 2021 for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA).
In September last year, GSK secured the Japanese Ministry of Health, Labour, and Welfare (MHLW) approval for its supplementary new drug application (sJNDA) for Nucala to treat chronic rhinosinusitis with nasal polyps (CRSwNP).