GSK plc, a prominent British pharmaceutical company, announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted data from the MATINEE study for review. This step is to support gaining a new indication for the usage of Nucala (mepolizumab) in treating chronic obstructive pulmonary disease (COPD).
The proposed indication seeks to establish Nucala as an additional maintenance therapy for COPD patients with an eosinophilic phenotype. Under the Prescription Drug User Fee Act (PDUFA), the target decision date has been set for May 7, 2025.
Mepolizumab functions as a monoclonal antibody specifically binding to interleukin-5 (IL-5), a significant cytokine in type 2 inflammation. Nucala targets various IL-5 mediated diseases intrinsic to type 2 inflammation management.
The recent application is underpinned by findings from the MATINEE study, which assessed the efficacy and safety of mepolizumab in 804 COPD patients exhibiting type 2 inflammation, identified by blood eosinophil counts.
Achieving its primary objective, the MATINEE study demonstrated that adding mepolizumab to ongoing inhaled maintenance therapy significantly reduced the annualized rate of moderate to severe exacerbations compared to placebo, with treatment duration spanning 52 to 104 weeks.
GSK intends to present MATINEE's findings at an upcoming scientific gathering, which will serve as a foundation for global regulatory filings.
COPD impacts over 390 million individuals worldwide, including more than 14 million in the United States. GSK emphasized that recurrent exacerbations heighten the strain on healthcare systems, with COPD-related medical and ancillary costs amounting to approximately $7 billion annually within the U.S.
Currently, Nucala is approved in the U.S. for four IL-5 mediated conditions. These encompass two respiratory indications: as an additional maintenance treatment for severe eosinophilic phenotype asthma in individuals aged six and older, and for adults experiencing chronic rhinosinusitis with nasal polyps (CRSwNP) who have inadequately responded to nasal corticosteroids.
Presently, Nucala does not have an approved indication for COPD in any region globally.
