TRYNGOLZA (olezarsen)
Severe hypertriglyceridemia · Adults with fasting triglycerides of at least 500 mg/dL
IONS · Ionis Pharmaceuticals, Inc.
完整時間線
5 個里程碑FDA approved TRYNGOLZA for severe hypertriglyceridemia
FDA approved olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
Ionis — TRYNGOLZA sHTG FDA approval↗Detailed CORE and CORE2 results were presented and published
The pivotal studies showed triglyceride reductions of up to 72% versus placebo and a significant reduction in acute-pancreatitis events; the data were presented at AHA and simultaneously published in the New England Journal of Medicine.
Ionis — CORE and CORE2 presentation and publication↗CORE and CORE2 reported positive topline results
Both Phase 3 studies met their primary endpoints, and the pooled analysis showed an 85% reduction in acute-pancreatitis events.
Ionis — Positive CORE and CORE2 topline results↗Phase 3 CORE2 study started
CORE2 began evaluating monthly olezarsen in adults with severe hypertriglyceridemia.
ClinicalTrials.gov — CORE2 study record (NCT05552326)↗相關新聞
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