Arrowhead Pharmaceuticals reported positive phase III top-line results for plozasiran (Redemplo) in adults with severe hypertriglyceridemia, setting up a supplemental NDA filing with the FDA before year-end. The studies met primary and prespecified secondary endpoints, and the company highlighted substantial triglyceride reductions after one year. In the two late-stage trials, once-every-three-month subcutaneous dosing drove median triglyceride declines of 79% and 81% versus roughly 27% in placebo arms. A pooled analysis also suggested fewer acute pancreatitis events among treated patients compared with control. Arrowhead said the regimen maintained favorable safety and tolerability, with no clinically meaningful liver-enzyme changes and no signals of hypersensitivity or abnormally low platelet counts. The readout further intensifies competition in lipid-lowering RNA medicines alongside Ionis’ Tryngolza (olezarsen), which recently gained FDA approval for severe hypertriglyceridemia.
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