China National Medical Products Administration Accepts Regulatory Submission for Nucala (mepolizumab) in Severe Eosinophilic Asthma

GSK today announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients with this condition.

The application is based on positive data from a phase III trial among Chinese patients and the global SEA development programme, which included three key clinical trials – DREAM, MENSA and SIRIUS – that established the efficacy and safety profile of mepolizumab for severe eosinophilic asthma patients. 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. The efficacy and safety of mepolizumab in the Chinese population were shown to be consistent with that in a non-Chinese population with SEA.

Asthma affects an estimated 46 million adults in China, with 6% experiencing severe asthma. Patients with SEA have an increased risk of exacerbations requiring hospitalisation or an increased likelihood of a potentially fatal asthma attack. 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.

Nucala is currently 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.