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. 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.

About Fasenra

Fasenra (benralizumab) is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).

Fasenra is AstraZeneca’s first respiratory biologic, now approved as an add-on maintenance treatment in severe eosinophilic asthma in the US, EU, Japan and other countries, with further regulatory reviews ongoing. In June 2019, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Fasenra self-administration and the Fasenra pen, a new auto-injector delivery device. Fasenra is in development for severe nasal polyposis, eosinophilic oesophagitis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome and chronic obstructive pulmonary disease.

Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd., Japan.

https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-granted-us-orphan-drug-designation-for-eosinophilic-oesophagitis-28082019.html