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GSK’s Nucala CRSwNP submission accepted in Japan
GSK’s Nucala CRSwNP submission accepted in Japan.
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[{"type":"text","content":"\n\nIssued: 01 September 2023, London UK\n \nGSK's regulatory submission accepted for review by Japanese regulator for use of Nucala (mepolizumab) in adults with chronic rhinosinusitis with nasal polyps\n \n· If approved, Nucala would be the first anti-interleukin-5 biologic available in Japan for the treatment of adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)\n· This would be the third indication for mepolizumab in Japan for an IL-5 mediated condition\n \nGSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients.\n \nThe sJNDA is based on results of the pivotal phase III MERIT trial which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP or eosinophilic chronic rhinosinusitis (ECRS) as well as data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP.1,2\nCRSwNP/ECRS affects 2-4% of the general population,2 In Japan, it is estimated that there are 2 million people with chronic sinusitis, of which about 200,000 are subject to surgery due to nasal polyps.3 CRSwNP is caused by chronic inflammation of the nasal lining.2 Elevated levels of IL-5 are associated with CRSwNP as a result of T2 inflammation, which can cause soft tissue growth, known as nasal polyps that develop in the sinuses and nasal cavity.2 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge.2 Surgery may be indicated for severe cases. However, polyps have a strong tendency to reoccur, often leading to repeat surgery.2\n \nIf approved, mepolizumab would be the first anti-IL-5 biologic for adult patients with inadequately controlled CRSwNP in Japan. Mepolizumab is approved in Japan as a treatment for bronchial asthma in children aged 6 years or older and in adults with refractory asthma whose symptoms are inadequately controlled with standard t...