AstraZeneca’s Fasenra Gains FDA Approval for Eosinophilic Granulomatosis with Polyangiitis, Expanding Treatment Options for Rare Autoimmune Disease

FDA Approval:
The FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease characterized by inflammation of blood vessels and elevated levels of eosinophils.

Clinical Trial Results:
The approval is based on the Phase 3 MANDARA trial, which showed that nearly 60% of Fasenra-treated patients achieved remission, comparable to those treated with GSK's Nucala (mepolizumab). Additionally, 41% of Fasenra-treated patients were able to fully taper off oral corticosteroids, compared to 26% in the Nucala group.

Treatment Expansion:
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries and is now the second biologic approved to treat EGPA.

Orphan Drug Designation:
Fasenra received Orphan Drug Designation for EGPA in 2018, recognizing its potential to address unmet medical needs in rare diseases.

Market Impact:
The approval is expected to enhance Fasenra's sales, which have already seen a year-over-year increase of 6% in the first half of 2024, driven by robust demand and expanding market share.