Nucala (mepolizumab) continues to gain approval around the world as a treatment for adults with COPD. The latest country to sign off is China, as its National Medical Products Administration approved the treatment as an add-on maintenance treatment for adult patients with inadequately controlled COPD characterized by raised blood eosinophils.
Manufacturer GSK said in a press release the approval was based on data from the MATINEE and METREX phase 3 trials, in which mepolizumab showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate to severe exacerbations compared to a placebo.
Mepolizumab is the first and only monthly biologic approved in China, where COPD deaths represent more than 30% of global COPD mortality.
“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,” said Kaivan Khavandi, MD, PhD, senior vice president and global head of respiratory, immunology and inflammation research and development for GSK. “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 hospitalizations, which account for a large proportion of annual direct medical costs.”
The drug’s approval in China follows its approval last year by the U.S. Food and Drug Administration and a recommendation from the European Medicines Agency.
