FDA Delays Decision on GSK's Nucala for COPD Beyond Target Date

Keywords

• FDA regulatory delay
• GSK's Nucala (mepolizumab)
• COPD label expansion
• PDUFA target date
• Respiratory biologic therapy
• Eosinophilic phenotype

Key Facts

The FDA has missed its May 7, 2025 target date for reviewing GSK's application to expand the label for Nucala (mepolizumab) to include chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype14. This represents another instance of regulatory delays at the FDA, as the agency continues to review the submission despite passing the official Prescription Drug User Fee Act (PDUFA) date1.

GSK's application is based on data from the MATINEE study, which demonstrated a significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations compared to placebo4. If approved, Nucala would become the first approved biologic with monthly dosing for COPD patients4.

This delay follows comments from FDA Commissioner Marty Makary who has previously noted that PDUFA dates are "target dates" the agency attempts to meet, rather than hard deadlines2. COPD affects more than 14 million people in the United States, with estimates of 500,000 hospitalizations and up to 1.3 million emergency department visits annually4.

The regulatory delay for Nucala raises questions about potential broader disruptions in the FDA's review processes and timelines for other pending drug applications in 20252.

Sources:

1. https://endpts.com/gsk-awaits-nucala-decision-after-fda-target-date-passes/

2. https://endpts.com/the-big-question-for-the-fda-after-stealths-pdufa-delay/

4. https://us.gsk.com/en-us/media/press-releases/us-fda-accepts-gsk-s-submission-for-the-use-of-nucala-mepolizumab-in-copd/