Fasenra - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation.
benralizumab
Post-authorisationHuman
On 19 September 2024, 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 Fasenra. The marketing authorisation holder for this medicinal product is AstraZeneca AB.
The CHMP adopted an extension to the existing indication as follows:
Eosinophilic granulomatosis with polyangiitis (EGPA)
Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (see section 5.1).
For information, the full indications for Fasenra will be as follows:1
Asthma
Fasenra is indicated as an add‑on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long‑acting β‑agonists (see section 5.1).
Eosinophilic granulomatosis with polyangiitis (EGPA)
Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (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 in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
CHMP post-authorisation summary of positive opinion for Fasenra (II-52)
AdoptedReference Number: EMA/422937/2024
English (EN) (129.61 KB - PDF)
First published: