Before the FDA approved AstraZeneca’s Fasenra, Nucala was the only therapy for treating eosinophilic granulomatosis with polyangiitis.

AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).

EGPA, previously known as Churg-Strauss syndrome, is a rare inflammatory disorder characterized by asthma, necrotizing vasculitis, extravascular granulomas, and blood and tissue eosinophilia. The rare immune-mediated vasculitis is caused by inflammation of blood vessels that can damage multiple organs and be fatal if left untreated.

AstraZeneca’s Fasenra (benralizumab) met its primary endpoint in the MANDARA trial by demonstrating non-inferiority to the current standard of care, GSK’s Nucala (mepolizumab), in patients with eosinophilic granulomatosis with polyangiitis (EGPA).