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EMA Filing acceptance for Nucala COPD
EMA Filing acceptance for Nucala COPD.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 24 March 2025, London UK\n \nGSK's application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European Medicines Agency\n \n· Submission based on data from MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations with mepolizumab versus placebo\n· Nucala (mepolizumab) could be the first biologic with monthly dosing for patients with COPD, if approved\n· More than 40 million people in Europe live with COPD, one of the leading causes of hospitalisation and death\n \n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.\n \nThe application is supported by results from the positive phase III MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations with mepolizumab compared to placebo.[1] The trial recruited patients across a wide spectrum of COPD phenotypes and clinical presentations. These data indicate that mepolizumab, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations. Results of MATINEE will be presented at a future scientific congress.\n \nIL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases.[2],[3],[4] This type of inflammation is detected in up to 40% of patients with COPD and is a major cause of symptoms and exacerbations that can lead to hospitalisation and/or emergency room visits.2-4\n \nCOPD affects more than 390 million people globally[5] and over 40 million people in Europe[6]. It is one of the leading causes of hospitalisation in many countries[7]. In 2021 alone, COPD had a societal cost of approximately 164 billion euros and resulted in more than 330,000 deaths in Europe.6 Recurrent exacerbations accelerate disease progression and further i...