FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Shoots Down GSK’s Mepolizumab for Treating COPD Patients

Sept. 12, 2018

The FDA issued GlaxoSmithKline a complete response letter for its mepolizumab application and said it wants to see more clinical data before it can approve the drug for chronic obstructive pulmonary disease (COPD) patients.

The application was for mepolizumab as an add on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in COPD patients.

The drug was first approved in 2015 for severe eosinophilic asthma and is believed to function by preventing IL-5 from binding to receptors on the surface of the white blood cells and reducing their number in the patient’s blood.

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