US FDA grants orphan drug designation to AstraZeneca's Fasenra.

M2 EQUITYBITES-August 30, 2019-US FDA grants orphan drug designation to AstraZeneca's Fasenra

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The US Food and Drug Administration has granted orphan drug designation to United Kingdom-based AstraZeneca's Fasenra (benralizumab) intended for the treatment of eosinophilic oesophagitis, it was reported yesterday.

The product was developed by AstraZeneca's MedImmune and was in-licensed from BioWa, a subsidiary of Japan-based Kyowa Hakko Kirin. It was granted the same status by the US FDA for the treatment of Eosinophilic Granulomatosis with Polyangiitis. It is a monoclonal antibody and has been designed to directly bind to the IL-5 receptor alpha on eosinophils.

The US FDA's orphan drug designation is granted to drugs and potential new medicines aimed at the treatment, diagnosis or prevention of rare diseases or disorders that affect less than 200,000 people in the United States.

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