GSK: FDA Accepts For Review Submission For New Indication Of Nucala In COPD

(RTTNews) - British drug maker GSK plc (GSK, GSK.L) announced Monday that the U.S. Food and Drug Administration 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) in chronic obstructive pulmonary disease or COPD.

The submission seeks an indication for the use of Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA) date is May 7, 2025.

Mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed to treat a range of IL-5 mediated diseases associated with type 2 inflammation.

The company noted that the latest 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. It achieved a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.

The company plans to present results of MATINEE at a future scientific congress. These results form the basis of regulatory submissions around the world.

COPD affects more than 390 million people globally and over 14 million people in the US. GSK noted that recurrent exacerbations add to pressures on healthcare systems, and the COPD -related medical costs and others cost the US healthcare system around $7 billion a year.

Nucala is currently approved for use in the US across four IL-5 mediated conditions. These include two respiratory indications as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype aged 6 years and older; and for adult patients with chronic rhinosinusitis with nasal polyps or CRSwNP and inadequate response to nasal corticosteroids.

Nucala is currently not indicated for COPD anywhere in the world.

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