GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled COPD characterised by raised blood eosinophils.

The approval was based on data from the positive MATINEE and METREX phase-III trials. Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype. The incidence of Adverse Events (AEs) was similar between placebo and mepolizumab groups.

Mepolizumab is the first and only monthly biologic approved in China and evaluated in COPD patients with a BEC starting as low as 150 cells/µL. Around 100 million people in China have COPD. Among those who continue to exacerbate despite inhaled triple therapy, about 67 percent have a BEC above 150 cells/µL. Recurrent exacerbations accelerates disease progression, higher hospitalisation and readmission rates, increased mortality and greater health system burden. COPD deaths in China represent over 30 percent of global COPD mortality.

Speaking in this regard, Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology and Inflammation R&D, GSK, said, “Given the high incidence of COPD in China and a mortality rate that is above the global average, there is a clear need for novel options to address COPD. The approval of Nucala offers patients in China a monthly add-on maintenance treatment to reduce exacerbations, including those leading to emergency department visits and/or hospitalisations which account for a large proportion of annual direct medical costs.” 

In both MATINEE and METREX trials, mepolizumab demonstrated a statistically significant reduction in the annualised rate of moderate or severe exacerbations compared with placebo, in patients with an eosinophilic phenotype, when added to triple inhaled therapy.

Mepolizumab is already approved in China as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older, as well as for adults with chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis. It is currently approved for use in COPD in the US. Regulatory submissions are under review globally, including in Europe where mepolizumab was recently granted a positive CHMP opinion in COPD.