From Triglyceride Reduction to Pancreatitis Prevention: FDA Approves Olezarsen & Approves the First Therapy Proven to Reduce Acute Pancreatitis Risk in Severe Hypertriglyceridemia<\/p>\n
\u2022\u2060 \u2060The U.S. FDA has approved olezarsen (Tryngolza), in combination with diet, for adults with severe hypertriglyceridemia (fasting triglycerides \u2265500 mg\/dL).
\n\u2022\u2060 \u2060Olezarsen is the first therapy specifically approved to reduce the risk of acute pancreatitis, in addition to lowering triglyceride levels.
\n\u2022\u2060 \u2060Approval 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.
\n\u2022\u2060 \u2060Once-monthly subcutaneous olezarsen reduced fasting triglycerides by 49%\u201372%.
\n\u2022\u2060 \u2060Fenofibrate remains the conventional first-line drug for severe hypertriglyceridemia because it lowers triglycerides by approximately 30%\u201350% 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.
\n\u2022\u2060 \u2060The most common adverse effects include injection-site reactions and elevated liver enzymes; liver function monitoring is recommended during treatment.
\n* Unlike fibrates\u2014particularly gemfibrozil\u2014olezarsen has not been associated with an increased risk of statin-related myopathy or rhabdomyolysis. Routine monitoring should focus on liver function tests.
\n\u2022\u2060 \u2060Olezarsen can be used alongside standard LDL-C\u2013lowering therapies, including statins, ezetimibe, and PCSK9 inhibitors and its primary target is triglyceride reduction, not LDL cholesterol.<\/p>\n
Source: U.S. Food and Drug Administration (FDA)<\/p>\n
Date: June 24, 2026<\/p>\n