FDA grants ODD for AstraZeneca’s Fasenra to treat EGPA

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for AstraZeneca’s Fasenra (benralizumab) to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that can cause damage to multiple organs and tissues.

Fasenra is AstraZeneca’s first respiratory biologic. The treatment was developed with the company’s global biologics research and development arm MedImmune and is in-licensed from BioWa.

AstraZeneca chief medical officer and global medicines development executive vice-president Sean Bohen said: "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."

AstraZeneca’s first respiratory biologic Fasenra is a monoclonal antibody that binds directly to IL-5 receptor α on eosinophils and attracts natural killer cells to induce rapid, as well as near-complete depletion of eosinophils through apoptosis.

Fasenra is currently approved as an add-on maintenance treatment in severe, eosinophilic asthma in the US, EU, Japan, and several other jurisdictions. Further regulatory reviews are ongoing.

Where approved, the biologic is available as a fixed-dose subcutaneous injection through a prefilled syringe given once every four weeks for the first three doses. Later on, it will be administered once every eight weeks.

The company has not yet started Phase III trials for Fasenra in EGPA, which was formerly known as Churg-Strauss Syndrome. It is characterised by inflammation of blood vessels and the presence of elevated levels of a type of white blood cell known as eosinophils.

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