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AstraZeneca's Fasenra Receives Orphan Drug Designation (ODD) For Hypereosinophilic Syndrome (HES)

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AstraZeneca's Fasenra Receives Orphan Drug Designation (ODD) For Hypereosinophilic Syndrome (HES)

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  • The FDA’s ODD for Fasenra follows its evaluation in P-II study assessing Fasenra vs PBO @12 weeks in patients with high level of eosinophils in blood and tissues 
  • The P-II study demonstrated meeting its 1EP with depleted blood eosinophils at week 12 and is conducted by United States NIH with Astrazeneca- published in H2’19
  • Fasenra (benralizumab) is a mAb- binds with IL-5 receptor on eosinophils and has received FDA’s ODD for eosinophilic granulomatosis with polyangiitis (EGPA) in Nov-2018 and is approved for severe eosinophilic asthma in the US- EU and Japan

Ref: AstraZeneca| Image: AstraZeneca

Click here to­ read the full press release 

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