GSK's COPD treatment approved by Chinese regulators

(Sharecast News) - Pharma giant GSK has received regulatory approval in China for its Nucala treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD). Following the green light from China's National Medical Products Administration, Nucala is the country's first and only monthly biologic for a COPD patient population with a blood eosinophil count of 150 cells/µL or higher.

Of the 100m people in China who have COPD, among those who continue to exacerbate despite inhaled triple therapy, around 67% have a blood eosinophil count above 150 cells/µL, GSK said.

The approval follows positive results from the Matinee and Metrex phase III trials, which showed a "clinically meaningful and statistically significant" reduction in the annualised rate of moderate to severe exacerbations compared with the placebo plus standard of care.

The trials, which GSK said included a wide spectrum of COPD patients with an eosinophilic phenotype, showed a similar incidence of adverse events between both the placebo and Nucala groups.

"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, senior vice president and global head of respiratory in GSK's Immunology & Inflammation R&D division.

"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."