Nucala - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
mepolizumab
Post-authorisationHuman
On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Nucala. The marketing authorisation holder for this medicinal product is GlaxoSmithKline Trading Services Limited.
The CHMP adopted a new indication as follows:
Chronic obstructive pulmonary disease (COPD)
Nucala is indicated in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) (see section 5.1).
For information, the full indications for Nucala will now be:
Severe eosinophilic asthma
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (see section 5.1).
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Chronic obstructive pulmonary disease (COPD)
Nucala is indicated in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) (see section 5.1).
Eosinophilic granulomatosis with polyangiitis (EGPA)
Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
Hypereosinophilic syndrome (HES)
Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause (see section 5.1).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold.
CHMP post-authorisation summary of positive opinion for Nucala (EMAVR0000257645)
Adopted
Reference Number: EMADOC-1700519818-2707697
English (EN) (135.51 KB - PDF)
First published: