Shots:
- The US FDA has approved AstraZeneca‘s Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause
- Approval was based on the P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks.
- Trial met its 1EP of delayed time to first HES worsening or flare & reduced the risk of HES worsening/flare by 65%. Trial also showed improvements across 2EPs, showing fewer flares, a decrease in the annualized rate of HES flares & sustained PROMIS Fatigue scores
Ref: AstraZeneca | Image: AstraZeneca | Press Release
Related News: AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer
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