FDA accepts GSK’s re-submission for Nucala

9 December 2024

After previously rejecting an application for this indication, the US Food and Drug Administration (FDA) has now accepted for review data from the MATINEE study to support the regulatory review process to obtain a new indication for Nucala (mepolizumab).

The resubmission by UK pharma major GSK (LSE: GSK) seeks authorization for Nucala as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA) date is May 7, 2025.

However, if the new indication is approved, Nucala will face fierce competition from Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals' (Nasdaq: REGN) mega blockbuster Dupixent (dupilumab), which gained US and European approval as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype earlier this year.

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