LONDON (dpa-AFX) - GSK plc (GSK.L) Friday said that the China National Medical Products Administration has approved Nucala for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
The approval is based on results from the phase 3 MERIT study, which evaluated mepolizumab versus placebo in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, and is supported by data from the global phase 3 SYNAPSE study, which explored the effect of mepolizumab versus placebo in more than 400 patients with CRSwNP.
Mepolizumab is already approved in China as an add-on maintenance treatment for individuals aged 12 years and older with severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis.
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