GSK: applies to the FDA for an expanded indication for Nucala

(CercleFinance.com) - GSK announces that the U.
S. Food & Drug Administration has agreed to review data from the MATINEE study for a potential expansion of the indication for Nucala (mepoliizumab) to maintenance therapy for patients with COPD (chronic obstructive pulmonary disease, a chronic respiratory disease characterized by persistent airway obstruction) with an eosinophilic phenotype.

The study showed a significant reduction in moderate to severe exacerbations over 52 to 104 weeks with the addition of mepolizumab to inhaled maintenance therapy.

The treatment targets type 2 inflammation, present in 40% of COPD patients, identified by an eosinophil blood test.

Full MATINEE results will be presented at a scientific congress, and the FDA decision is expected by May 7, 2025, GSK says.

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