FDA approves Ionis' TRYNGOLZA as first treatment to reduce triglycerides and acute pancreatitis risk in severe hypertriglyceridemia

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The U.S. Food and Drug Administration has approved Ionis Pharmaceuticals' TRYNGOLZA as the first and only treatment indicated to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia. TRYNGOLZA, available in 50 mg or 80 mg doses self-administered once monthly via an autoinjector, was approved based on Phase 3 CORE and CORE2 studies showing it lowered fasting triglyceride levels by up to 72% compared to placebo at six months and reduced acute pancreatitis events by up to 91%. Among patients with baseline and 12-month data, 86% achieved triglyceride levels below 500 mg/dL, a critical threshold for reducing acute pancreatitis risk. The number needed to treat over one year to prevent one episode of acute pancreatitis was 20 in the overall cohort and four in patients with triglycerides of at least 880 mg/dL and a prior history of acute pancreatitis. Ionis plans to launch TRYNGOLZA in the U.S. in July, marking its first independent commercial launch in a prevalent condition.

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Biotech & Genomic Medicine · 1 stocks
Ionis Pharmaceuticals Inc
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FDA approval of TRYNGOLZA as first treatment for severe hypertriglyceridemia, based on Phase 3 data showing significant triglyceride reduction and pancreatitis risk reduction.

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