AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE).
EoE is a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the oesophagus causing injury and inflammation.1 The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Eosinophilic oesophagitis is an allergic inflammatory disease that can affect children and adults, and typically patients experience a range of debilitating symptoms including severe pain and difficulty swallowing food. Currently there are no FDA-approved treatments for eosinophilic oesophagitis. Because Fasenra depletes eosinophils in blood and tissue, it could become a potential new medicine to treat patients with this rare disease.”
Fasenra is AstraZeneca's first respiratory biologic medicine and is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma in the US, EU, Japan and other countries. In November 2018, the FDA granted ODD for Fasenra for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), and also granted ODD for the treatment of hypereosinophilic syndrome (HES) in February 2019.