China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
If given approval, Nucala will become the first targeted anti-Interleukin-5 (IL-5) treatment in the country for adult and adolescent patients with SEA.
A first-in-class monoclonal antibody to target IL-5, Nucala was first approved in 2015 for SEA in the US.
It prevents IL-5 from binding to its receptor on the surface of eosinophils, lowering blood eosinophils and maintains them under normal levels.
The application to China National Medical Products Administration has been submitted based on positive data from Phase III trial undertaken on patients in China and the global SEA development programme, which included three important clinical trials – DREAM 2, MENSA3 and SIRIUS4.
These trials established the efficacy and safety profile of mepolizumab for SEA patients.
The Phase III trial for 52 weeks studied the impact of mepolizumab as adjunctive therapy in Chinese patients with SEA. The primary endpoint was reduction, relative to placebo, in the annual rate of clinically significant exacerbations.
The efficacy and safety of mepolizumab in the Chinese population were found to be consistent with that in non-Chinese population suffering with SEA.
Asthma impacts an estimated 46 million adults in China, with 6% experiencing severe asthma.
Patients suffering with SEA have a higher risk of exacerbations and need hospitalisation or experience a potentially fatal asthma attack.
Currently, Nucala is approved in the country for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA).
It was also included on the National Reimbursement Drug List earlier this year.
Presently, Nucala is not approved in the country for the treatment of SEA.