GSK plc (GSK.L) Thursday reported positive results from Phase 3 MATINEE study evaluating Nucala for the treatment of chronic obstructive pulmonary disease (COPD).
In the study, Nucala showed a clinically meaningful and statistically significant 21% reduction in the annualised rate of moderate/severe exacerbations in a wide spectrum of patients with COPD, versus placebo, meeting the primary endpoint.
Additionally, in a post-hoc analysis of patients with chronic bronchitis only, Nucala showed a 31% reduction in the annualised rate of moderate/severe exacerbations versus placebo. A secondary endpoint of the study was also met showing 35% reduction in the annualised rate of exacerbations leading to emergency department visits and/or hospitalisation versus placebo.
These results were published in the New England Journal of Medicine.
Regulatory submissions for Nucala for the treatment of COPD are under review in many countries including the U.S., China and the EU. A decision from the FDA is expected on May 7, 2025.
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