GSK says US agrees to look at data for new use of COPD drug
By Frank Prenesti
Date: Monday 09 Dec 2024
(Sharecast News) - GSK said the US Food and Drug Administration has agreed to look at data from its MATINEE study to support the regulatory review process to obtain a new use of its Nucala drug as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).
The 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.
The submission is based on data from GSK's MATINEE study, which evaluated the efficacy and safety of the drug, also known as mepolizumab, in 804 patients with COPD who have evidence of type 2 inflammation characterised by blood eosinophil count.
Patients with broad clinical presentations including hard to treat patients with emphysema-only, chronic bronchitis only, or a mix of both, were recruited.
"COPD affects more than 390 million people globally and over 14 million people in the US, exerting a significant burden on healthcare resources and the lives of patients," GSK said on Monday.
"Recurrent exacerbations add to pressures on healthcare systems and account for a large proportion of the annual direct medical costs of COPD with emergency department visits and inpatient care costing the US healthcare system around $7bn 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 patients with severe asthma with an eosinophilic phenotype aged six years and older and as an add-on maintenance treatment for adult patients with chronic rhinosinusitis with nasal polyps and inadequate response to nasal corticosteroids.
Reporting by Frank Prenesti for Sharecast.com
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