The FDA Has Accepted For Review GSK's Nucala (Mepolizumab) As An Add-on Maintenance Treatment For Patients With Chronic Obstructive Pulmonary Disease With An Eosinophilic Phenotype, With Prescription Drug User Fee Act Date Is 7 May 2025
GlaxoSmithKline plc Sponsored ADR -0.14%
GlaxoSmithKline plc Sponsored ADR
GSK
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48.81
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-0.14%
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- Submission supported by MATINEE data showing a significant and clinically meaningful reduction in annualized rate of moderate/severe exacerbations compared with placebo.
- Nucala could be the first approved biologic with monthly dosing for patients with COPD.
- COPD affects more than 14 million people in the US with estimates of 500,000 hospitalizations and up to 1.3 million emergency department visits each year.