GSK’s Nucala Demonstrates Efficacy in COPD with Positive Phase III Trial Results

Phase III Success:
GSK's Nucala (mepolizumab) has shown a statistically significant and clinically meaningful reduction in the annualized rate of moderate or severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) compared to placebo in the Phase III MATINEE trial.

Trial Design:
The MATINEE trial was a multi-center, randomized, placebo-controlled, double-blind, parallel-group study involving 806 patients aged 40 years and older with COPD. Patients received Nucala or placebo as an add-on to their optimized maintenance COPD therapy for at least 52 weeks and up to 104 weeks.

Safety Profile:
Preliminary safety results from the MATINEE trial were consistent with Nucala's known safety profile.

Regulatory Submission:
GSK plans to submit the results to regulatory authorities to support approval for Nucala's use in COPD, with expected submissions in the EU and Canada in 2025.

Market Context:
Nucala, if approved for COPD, will compete with other drugs like Verona's Ohtuvayre and Sanofi and Regeneron's Dupixent, which is awaiting approval for COPD later this month.

Current Indications:
Nucala is currently approved for severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).