Olezarsen Achieves Up to 72% Triglyceride Reduction in Phase 3 sHTG Trials
Reuters
Nov 08, 2025
Olezarsen Achieves Up to 72% Triglyceride Reduction in Phase 3 sHTG Trials
Swedish Orphan Biovitrum AB (Sobi) has announced positive results from the pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen in patients with severe hypertriglyceridemia (sHTG). The results were presented as a late breaker at the American Heart Association 2025 Scientific Sessions. The studies achieved the primary endpoint, with olezarsen demonstrating a placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, with reductions sustained through 12 months. Nearly 1,100 patients participated in the trials, which required standard of care lipid-lowering therapy. Olezarsen showed a favorable safety and tolerability profile, with adverse and serious adverse events balanced or less frequent compared to placebo. An open-label extension study is ongoing, and Sobi plans to submit a marketing authorization application for olezarsen in mixed chylomicronemia syndrome $(MCS)$ to the EMA in 2026, while its partner Ionis intends to submit a supplemental new drug application for sHTG to the FDA by the end of this year.
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