AstraZeneca Receives FDA Approval for Fasenra in Eosinophilic Granulomatosis with Polyangiitis

AstraZeneca today announced that the FDA has approved Fasenra (benralizumab) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, systemic vasculitis characterized by eosinophilic inflammation affecting multiple organs. In the Phase 3 MANDARA trial, Fasenra demonstrated a statistically significant improvement in the proportion of patients achieving remission compared to mepolizumab. Fasenra is an anti-IL-5Rα antibody that depletes eosinophils through antibody-dependent cellular cytotoxicity. This approval expands Fasenra's use into EGPA, adding to its existing approvals in severe eosinophilic asthma.