Biopharmaceutical company GSK plc (LSE/NYSE:GSK) announced on Friday that China's National Medical Products Administration has approved Nucala (mepolizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
Nucala is a monoclonal antibody targeting interleukin-5 (IL-5). This approval marks its third indication in China for an IL-5-mediated condition.
The decision was based on data from two phase III trials which evaluated mepolizumab's efficacy and safety in patients with CRSwNP.
CRSwNP affects an estimated 30 million people in China and can significantly impact quality of life.
Nucala is approved as an add-on therapy with intranasal corticosteroids for adults whose disease is inadequately controlled with other treatments. It offers a non-surgical option and an alternative to repeated exposure to oral corticosteroids, said Kaivan Khavandi, SVP, global head of Respiratory/Immunology R&D at GSK.
Mepolizumab is already approved in China as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis.
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