Business
Nucala NDA accepted for review in China
Nucala NDA accepted for review in China.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n Issued: 14 March 2023, London UK\n \n \n \n \n \n \n \n \n China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma\n \n \n \n \n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that the ChinaNational Medical Products Administration hasaccepted for review a new drug application for Nucala (mepolizumab) as an add-on\n maintenance treatment for severe eosinophilic asthma (SEA). If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in Chinafor adult and adolescent patients with this condition.\n \n \n \n \n \n The application is based on positive data from\n a phase III trial among Chinese patients1 and the global SEA development programme, which included three key clinical trials - DREAM2, MENSA3 and SIRIUS4 - that established the efficacy and safety profile of mepolizumab for severe eosinophilic asthma patients.\n The 52-week phase III trial in Chinese patients studied the effect of mepolizumab as adjunctive therapy in patients with SEA with a primary endpoint of reduction, relative to placebo, in the annual rate of clinically significant exacerbations.1 The efficacy and safety of mepolizumab in the Chinese population were shown to be consistent with that in a non-Chinese population with SEA.2-5\n \n \n \n \n \n Asthma affects an estimated 46 million adults in China, with\n 6% experiencing severe asthma.6-8\n \n \n Patients with SEA have an increased risk of exacerbations requiring hospitalisation or an increased likelihood of a potentially fatal asthma attack.9,10 Guidelines for bronchial asthma prevention and management (2020 edition) from the Asthma group of the Chinese Thoracic Society reference the current unmet need among Chinese patients with SEA.11\n \n \n \n \n Nucala\n \n is currently\n approved in China for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA) and was included on the National Reimbursement Drug List in January 2023. However, Nucala is not currently approved in China for the treatment of SEA.\n \n \n \n \n \n \n About Nucala (mepolizumab)\n \n \n \n First approved in 2015 for SEA in the US, Nucala is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its rece...