AstraZeneca’s Fasenra (benralizumab) has been granted orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of eosinophilic oesophagitis (EoE).
Fasenra, which was developed by AstraZeneca’s MedImmune, was in-licensed from BioWa, a subsidiary of Japan-based Kyowa Hakko Kirin.
Prior to receiving the orphan drug designation for eosinophilic oesophagitis, the respiratory biologic medicine was granted the same status by the FDA for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). In February, the same status was granted by the FDA for the treatment of hypereosinophilic syndrome (HES).
Eosinophilic oesophagitis is a rare, chronic, inflammatory disease. It occurs when a type of white blood cell called eosinophils accumulates in the oesophagus, leading to injury and inflammation.
The FDA’s orphan drug designation is granted to drugs and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that impact less than 200,000 people in the US.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos 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 a monoclonal antibody, which has been designed to directly bind to the IL-5 receptor alpha on eosinophils. The monoclonal antibody is said to attract natural killer cells to trigger rapid and near-complete depletion of eosinophils through programmed cell death.
In the US, EU, Japan and other countries, the respiratory biologic is approved as an add-on maintenance treatment in severe eosinophilic asthma. Apart from eosinophilic oesophagitis, the drug is in development for severe nasal polyposis, eosinophilic granulomatosis with polyangiitis, chronic obstructive pulmonary disease, and hypereosinophilic syndrome.
In another development, AstraZeneca said that the phase 3 trial ETHOS evaluating the triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) met the endpoint. The ETHOS trial is being carried out in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).