GSK application to expand use of Nucala for COPD accepted for review by EMA
IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases.;
London: GSK plc has 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.
The 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. 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.
IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases. 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.
COPD affects more than 390 million people globally and over 40 million people in Europe. It is one of the leading causes of hospitalisation in many countries. In 2021 alone, COPD had a societal cost of approximately 164 billion euros and resulted in more than 330,000 deaths in Europe. Recurrent exacerbations accelerate disease progression and further increase the risk of hospitalisation, adding to pressures on healthcare systems through emergency department visits and inpatient care.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.