US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD

GSK

9 December 2024 - Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations compared with placebo.

GSK today announced the US FDA has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for the use of Nucala (mepolizumab), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype.

Read GSK press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier