GSK’s Nucala approved by the European Commission for the treatment of chronic obstructive pulmonary disease

GSK has recently announced the European Commission has approved Nucala, which is a monoclonal antibody targeting interleukin-5, in adults as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist.

This was based on data from the positive MATINEE phase III trial in which mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype.

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic shown to significantly reduce exacerbations, which can lead to irreversible lung damage, hospitalisations and emergency department visits. Nucala could offer relief to the millions of Europeans who need additional options beyond inhaled triple therapy to manage their COPD.”

Susanna Palkonen, Director, European Federation of Allergy and Airways Diseases Patients’ Associations (EFA), said: “The burden for patients living with COPD is immense, especially for those facing continued exacerbations and repeated hospitalisations. We welcome, and our community celebrates, new treatment options for COPD patients as they are desperately needed.”

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Related Topics and Keywords

chronic obstructive pulmonary disease, GSK, Nucala (mepolizumab), Nucala®