GSK has announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with inadequately controlled COPD characterized by elevated blood eosinophils.

 

The approval is based on positive results from the MATINEE and METREX Phase III trials, in which mepolizumab significantly reduced the annualized rate of moderate to severe exacerbations compared with placebo plus standard care. Adverse events were similar between groups.

 

Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL. COPD affects around 100 million people in China, and among those who continue to exacerbate despite triple inhaled therapy, roughly 67% have a BEC above 150 cells/µL. Recurrent exacerbations accelerate disease progression, increase hospitalizations, and drive mortality, with China accounting for over 30% of global COPD deaths.

 

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D at 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 the MATINEE and METREX trials, mepolizumab added to triple inhaled therapy reduced the annualized rate of moderate or severe exacerbations compared with placebo.