GSK has received approval from the China National Medical Products Administration for Nucala (mepolizumab) as an add-on maintenance therapy for severe eosinophilic asthma in adults and adolescents aged 12 years and above.
Nucala, a first-in-class monoclonal antibody targeting anti-interleukin-5 (IL-5), was first approved in the US in 2015 for severe asthma with an eosinophilic phenotype.
Mepolizumab works by binding to and inhibiting IL-5 molecules.
The latest approval is supported by a Phase III trial conducted in China, which supports the efficacy and safety of mepolizumab established by the global clinical development programme.
The programme included the DREAM, MENSA, SIRIUS and MUSCA trials, which have demonstrated mepolizumab’s benefits in severe asthma management.
In the 52-week trial in China, mepolizumab significantly reduced the annual rate of clinically significant exacerbations compared with placebo.
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Patients with severe asthma on mepolizumab also reported a 70% reduction in exacerbations requiring hospitalisation or emergency department visits and a longer duration before their next exacerbation.
This marks the second indication for mepolizumab in the country, following its approval in 2021 for eosinophilic granulomatosis with polyangiitis.
GSK research and development respiratory and immunology global head, senior vice-president Kaivan Khavandi stated: “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.”
Nucala has been approved in the US, the EU and more than 25 other markets for severe asthma treatment and has been studied in more than 4,000 patients across 41 clinical trials for IL-5-mediated conditions.
GSK has also agreed to acquire asthma drug specialist Aiolos Bio in a $1.4bn deal as it strengthens its respiratory and inflammatory asset pipeline.
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