From Triglyceride Reduction to Pancreatitis Prevention: FDA Approves Olezarsen & Approves the First Therapy Proven to Reduce Acute Pancreatitis Risk in Severe Hypertriglyceridemia
From Triglyceride Reduction to Pancreatitis Prevention: FDA Approves Olezarsen & Approves the First Therapy Proven to Reduce Acute Pancreatitis Risk in Severe Hypertriglyceridemia
• The U.S. FDA has approved olezarsen (Tryngolza), in combination with diet, for adults with severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL).
• Olezarsen is the first therapy specifically approved to reduce the risk of acute pancreatitis, in addition to lowering triglyceride levels.
• Approval was based on two phase 3 trials of more than 1,000 patients with severe hypertriglyceridemia, who had a mean baseline triglyceride level of 1,116 mg/dL.
• Once-monthly subcutaneous olezarsen reduced fasting triglycerides by 49%–72%.
• Fenofibrate remains the conventional first-line drug for severe hypertriglyceridemia because it lowers triglycerides by approximately 30%–50% and is widely recommended to reduce pancreatitis risk. However, its benefit is supported mainly by expert consensus and indirect evidence, rather than randomized clinical trials specifically proving pancreatitis reduction.
• The most common adverse effects include injection-site reactions and elevated liver enzymes; liver function monitoring is recommended during treatment.
* Unlike fibrates—particularly gemfibrozil—olezarsen has not been associated with an increased risk of statin-related myopathy or rhabdomyolysis. Routine monitoring should focus on liver function tests.
• Olezarsen can be used alongside standard LDL-C–lowering therapies, including statins, ezetimibe, and PCSK9 inhibitors and its primary target is triglyceride reduction, not LDL cholesterol.
Source: U.S. Food and Drug Administration (FDA)
Date: June 24, 2026
