GSK announces U.S. FDA accepted its submission for use of Nucala in COPD

GSK (GSK) announced the US Food and Drug Administration, 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, 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 7 May 2025. The submission is based on data from the MATINEE study, which evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterised by blood eosinophil count. The MATINEE study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.