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TRYNGOLZA® (olezarsen) approved by the FDA as the first and only treatment to reduce triglycerides and the risk of acute pancreatitis in patients with severe hypertriglyceridemia (sHTG)

IONS
  • The FDA approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG) defined as triglycerides ≥500 mg/dL.
  • TRYNGOLZA is the only approved therapy indicated to reduce the risk of acute pancreatitis in sHTG patients.
  • The medication is self-administered once monthly via autoinjector in 50 mg or 80 mg doses.
  • Phase 3 CORE & CORE2 studies demonstrated TRYNGOLZA lowered fasting triglycerides by up to 72% compared to placebo at six months, with reductions sustained at 12 months.
  • Clinical trials showed a significant reduction in acute pancreatitis events by up to 91% (pooled reduction of 85%).
  • Among patients with baseline & 12-month data, 86% achieved triglyceride levels below 500 mg/dL.
  • The number needed to treat over one year to prevent one acute pancreatitis episode was 20 in the overall cohort & 4 in high-risk patients (triglycerides ≥880 mg/dL with prior pancreatitis history).
  • Common adverse reactions included injection site reactions & liver enzyme increases, which were more frequent with the 80 mg dose.
  • TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to the drug or its excipients.
  • Warnings include potential hypersensitivity reactions & liver enzyme abnormalities requiring monitoring before initiation & dose adjustments.
  • The drug will be available in the U.S. starting in July.
  • Ionis will host a webcast at 3:30 p.m. ET to discuss the FDA approval.
  • TRYNGOLZA is also approved for familial chylomicronemia syndrome (FCS), a rare form of sHTG.
  • Ionis Every Step™ will provide support services including nutrition information, injection training, & financial assistance.