Biopharmaceutical company AstraZeneca Plc (LON:AZN) announced on Wednesday the grant of Orphan Drug Designation (ODD) to Fasenra (benralizumab) by the US Food and Drug Administration (FDA) 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.
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.
Fasenra was developed by AstraZeneca and is in-licensed from BioWa Inc, a wholly-owned subsidiary of Kyowa Hakko Kirin Co Ltd, Japan.
AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.
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