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 21 May 2026, 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 a new indication as follows:
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).
Hypereosinophilic syndrome (HES)
Fasenra is indicated as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause (see section 4.2 and 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 Fasenra (VR/0000288520)
Adopted
Reference Number: EMADOC-1700519818-3115823
English (EN) (137.51 KB - PDF)
Opublikowane po raz pierwszy: