AstraZeneca’s Fasenra Receives Orphan Drug Designation (ODD) For Hypereosinophilic Syndrome (HES)
Shots:
- 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
Click here read full press release/ article | Ref: AstraZeneca | Image: Rte