The Food and Drug Administration (FDA) has granted Orphan Drug designation to benralizumab (Fasenra; AstraZeneca) for the treatment of eosinophilic esophagitis (EoE).

EoE is a rare, chronic, inflammatory disease that occurs when eosinophils accumulate in the esophagus. The disease may manifest in patients with symptoms of chronic pain, difficulty swallowing, poor growth, malnutrition, and weight loss. Benralizumab is a monoclonal antibody (IgG1, kappa) that binds to the interleukin-5 receptor alpha expressed on the surface of eosinophils and basophils causing apoptosis. Currently, there are no FDA-approved treatments for EoE.

Mene Pangalos, Executive VP, BioPharmaceuticals R&D, said, “Because Fasenra depletes eosinophils in blood and tissue, it could become a potential new medicine to treat patients with this rare disease.”

The FDA has also granted Orphan Drug designation to benralizumab for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in November 2018 and for the treatment of hypereosinophilic syndrome (HES) in February 2019.

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Benralizumab is currently approved under the brand name Fasenra as add-on maintenance treatment of severe asthma in patients aged ≥12 years, and with an eosinophilic phenotype. It is supplied as a 30mg/mL strength subcutaneous injection in single-dose prefilled syringes.

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