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AstraZeneca Receives the US FDA's Orphan Drug Designation for its First Respiratory Biologic Fasenra (benralizumab) to Treat Eosinophilic Esophagitis

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AstraZeneca Receives the US FDA's Orphan Drug Designation for its First Respiratory Biologic Fasenra (benralizumab) to Treat Eosinophilic Esophagitis

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  • The US FDA has granted orphan drug designation to Fasenra (benralizumab) for the treatment of eosinophilic esophagitis (EoE) following OD designation for EGPA in Nov’2018 and for hypereosinophilic syndrome in Feb’2019             
  • The FDA’s OD designation is granted to the new therapies intended for the treatment- diagnosis or prevention of rare diseases or disorders that affect fewer than 200-000 people in the US
  • Fasenra is a mAb targeting IL-5 receptor alpha on eosinophils- attracting NK cells to induce depletion of eosinophils via apoptosis and has received approval as an add-on maintenance treatment for severe- eosinophilic asthma in the US- EU- Japan

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Ref: AstraZeneca | Image: AstraZeneca


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