Olezarsen Achieves Up to 72% Triglyceride Reduction in Phase 3 sHTG Trials

Reuters
2025/11/08
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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Swedish Orphan Biovitrum AB published the original content used to generate this news brief on November 08, 2025, and is solely responsible for the information contained therein.

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