GSK Receives Approval for Nucala in China, Targeting COPD

GSK plc (LSE/NYSE: GSK) announced that China's National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by elevated blood eosinophils.

This approval marks an expansion for Nucala, already approved in other regions for COPD and other eosinophilic conditions.

The approval is based on data from the MATINEE and METREX phase III trials, where mepolizumab demonstrated a statistically significant reduction in the annualised rate of moderate/severe exacerbations compared to placebo in COPD patients with an eosinophilic phenotype. The data included a reduction in exacerbations leading to hospitalisation and/or emergency department visits.

Headline Numbers:

• Efficacy: MATINEE trial showed a rate ratio of 0.79 (p=0.01), equating to 0.80 exacerbations per year with mepolizumab versus 1.01 with placebo. METREX trial showed a rate ratio of 0.82 (adjusted p=0.04), or 1.40 exacerbations per year with mepolizumab versus 1.71 with placebo.
• Target Population: Approximately 67% of COPD patients inadequately controlled on inhaled triple therapy have a blood eosinophil count above 150 cells/µL, making them potential candidates for Nucala treatment.
• Market Size: China has around 100 million people with COPD, representing over 30% of global COPD mortality.

The approval positions Nucala as the first and only monthly biologic in China studied in a broad COPD population with blood eosinophil counts starting as low as 150 cells/µL. This is particularly relevant as recurrent exacerbations significantly worsen disease progression, hospitalization rates, and mortality, creating a substantial healthcare burden.

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK stated, “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.”