Arrowhead Pharmaceuticals IncPhase 3 trials show plozasiran significantly reduces triglycerides and pancreatitis events, supporting FDA filing.

Arrowhead Pharmaceuticals announced that its drug plozasiran significantly reduced triglyceride levels and acute pancreatitis events in two Phase 3 studies, SHASTA-3 and SHASTA-4, involving patients with severe hypertriglyceridemia. The trials met primary and secondary endpoints, with median triglyceride reductions of 79% and 81% after 12 months. A pooled analysis showed a 78% reduction in acute pancreatitis events, with a 91% reduction in high-risk patients. The company plans to file a supplemental New Drug Application with the FDA by end of 2026, using a Priority Review Voucher. Plozasiran, marketed as Redemplo, is already approved for familial chylomicronemia syndrome and uses RNA interference to suppress APOC3 production.
Arrowhead Pharmaceuticals IncPhase 3 trials show plozasiran significantly reduces triglycerides and pancreatitis events, supporting FDA filing.