GSK Receives EU Approval for Nucala in COPD Treatment

GSK plc (LSE/NYSE: GSK) announced that the European Commission has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled Chronic Obstructive Pulmonary Disease (COPD) characterized by raised blood eosinophils.

The approval hinges on positive results from the MATINEE phase III trial, which demonstrated a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe COPD exacerbations versus placebo, when added to standard inhaled therapies. Nucala stands out as the first and only monthly biologic in the EU evaluated across a wide COPD population exhibiting an eosinophilic phenotype.

COPD presents a substantial global health challenge, affecting over 390 million individuals worldwide, including approximately 40 million in Europe. The disease is projected to become the leading cause of hospital admissions in the coming decade. Data from the MATINEE trial also showed a reduction in exacerbations leading to emergency department visits and/or hospitalisations compared to placebo, further underscoring Nucala's potential.

Driver Breakdown:

• Efficacy: Nucala demonstrated a statistically significant reduction in the annualised rate of moderate or severe exacerbations compared with placebo (rate ratio 0.79, P=0.01).
• Hospitalisations: The annualised rate of COPD exacerbations requiring ED visits and/or hospitalisation was reduced in the mepolizumab group (rate ratio 0.65).
• Market Opportunity: With millions of COPD patients in Europe seeking better management options, Nucala addresses a significant unmet need.

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic shown to significantly reduce exacerbations, which can lead to irreversible lung damage, hospitalisations and emergency department visits. Nucala could offer relief to the millions of Europeans who need additional options beyond inhaled triple therapy to manage their COPD.”