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# GSK Files for Nucala COPD Indication
- URL: https://www.fdaweb.com/gsk-files-for-nucala-copd-indication/
- Published: 2024-12-09T12:00:00.000Z
- Updated: 2026-09-14T14:48:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158324

FDA has accepted for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype. The agency has set a user fee review action target date of 5/7/2025\. The monoclonal antibody was first approved in 2015 for severe asthma with an eosinophilic phenotype. It is said to work by targeting and binding to interleukin-5, a key messenger protein (cytokine) in Type 2 inflammation.

The submission is based on data from the 804-patient MATINEE study, which met its primary endpoint of achieving a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo.