Shots:
- P-III (SHASTA-3 & 4) trials, assessing Redemplo (25mg, SC, Q3M) vs PBO in sHTG adults (n=757), met their 1 & 2EPs, showing median TG reductions of 79% & 81%, respectively, at 12mos. In pts with TG ≥880mg/dL, median TG reductions were 85% in both trials
- At 12mos., Redemplo enabled 91% & 93% pts in SHASTA-3 & 4 to achieve TG <500 mg/dL vs 51% & 50%, while 52% & 55% reached TG <150 mg/dL v 7.9% & 2%, alongside significant reductions in APOC3, VLDL-C & non-HDL cholesterol
- In pooled analyses, Redemplo reduced all acute pancreatitis (AP) events by 78% vs PBO (NNT 24) & risk of a first AP event; among pts with TG ≥500mg/dL & prior AP, AP event rates fell 91%, with an NNT of 3; sNDA to be filed with US FDA by 2026-end, using a Priority Review Voucher
Ref: Businesswire | Image: Arrowhead | Press Release
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