FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Fasenra Receives Orphan Drug Designation

Dec. 5, 2018

AstraZeneca’s Fasenra (benralizumab), a treatment for eosinophilic granulomatosis with polyangiitis (EGPA), received an orphan drug designation from the FDA.

The rare autoimmune disease causes blood vessels to become inflamed and can damage multiple organs and tissues. It is also characterized by the presence of increased eosinophil, a type of white blood cell.

AstraZeneca’s first respiratory biologic, the drug induces rapid and near-complete removal of eosinophils in the blood and has demonstrated efficacy in severe eosinophilic asthma, suggesting it may be beneficial to patients with EGPA. It is currently approved as an add-on maintenance treatment for severe eosinophilic asthma.

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