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New Indication Alert: AstraZeneca’s Fasenra® FDA-Approved for EGPA

Sep 18, 2024

On 18 September 2024, AstraZeneca announced that its Fasenra® (benralizumab) has been approved by the FDA for eosinophilic granulomatosis with polyangiitis (EGPA).  The approval was based on positive results from a Phase 3 trial (MANDARA) comparing the efficacy and safety of Fasenra® to mepolizumab, which was previously the only approved EGPA treatment.

Fasenra® has previously been approved for mo severe eosinophilic asthma in over 80 countries, including the US, Japan, EU and China.