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FDA grants AstraZeneca’s Fasenra Orphan Drug Designation

Sean Bohen

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200 000 people in the US.

“EGPA is a rare, but debilitating inflammatory disease and patients with the disease typically have very high levels of eosinophils. Our clinical trials for Fasenra in severe, eosinophilic asthma show it depletes eosinophils and we are exploring the potential of this medicine to address unmet medical needs in other eosinophil-driven diseases,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer.

AstraZeneca’s first respiratory biologic

EGPA is characterised by inflammation of blood vessels and the presence of elevated levels of eosinophils, a type of white blood cell. Fasenra induces rapid and near-complete depletion of eosinophils in the blood and has provenefficacy in severe, eosinophilic asthma, which suggests it may benefit patients with EGPA.

Fasenra is AstraZeneca’s first respiratory biologic and is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma in the US, EU, Japan and several other jurisdictions.