FDA approves olezarsen for severe hypertriglyceridemia
Olezarsen has been approved by the FDA to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
The U.S. Food and Drug Administration (FDA) has approved olezarsen as an adjunct to diet for reducing triglyceride levels and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (triglycerides ≥500 mg/dL). It is the first therapy approved for both indications in this population.
The approval is based on the phase 3 CORE and CORE2 trials, in which monthly subcutaneous olezarsen reduced fasting triglyceride levels by up to 72% versus placebo at 6 months, with reductions maintained through 12 months. Olezarsen also reduced acute pancreatitis events by up to 91%. Among participants with baseline and 12-month data, 86% achieved triglyceride levels below 500 mg/dL. Across the clinical program, olezarsen demonstrated a favorable safety and tolerability profile.
Olezarsen is an antisense oligonucleotide targeting apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism. The drug was previously approved in the US and EU for familial chylomicronemia syndrome (FCS); the new indication expands its use to the broader population of adults with severe hypertriglyceridemia.