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.