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# More Data Needed on Glaxo COPD Add-on Drug
- URL: https://www.fdaweb.com/more-data-needed-on-glaxo-copd-add-on-drug/
- Published: 2018-09-10T12:00:00.000Z
- Updated: 2026-09-15T00:30:47.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5142309

FDA has issued GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts. The letter states that more clinical data are required to support an approval decision. The company says it will work closely with the agency to determine the appropriate next steps.

  
Mepolizumab is a first-in-class monoclonal antibody that targets IL-5, and was first approved in 2015 for severe eosinophilic asthma. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, the company says. Inhibiting IL-5 binding in this way reduces blood eosinophils.