FDA Grants Breakthrough Therapy Designation to Ionis Pharmaceuticals' Olezarsen for Severe Hypertriglyceridemia
Ionis Pharmaceuticals Inc. has received Breakthrough Therapy designation from the FDA for its drug olezarsen, aimed at reducing triglyceride levels in adults with severe hypertriglyceridemia. This designation is based on successful Phase 3 studies showing significant reductions in triglyceride levels and acute pancreatitis events. Ionis plans to submit a supplemental new drug application to the FDA by year-end.
Ionis Pharmaceuticals Inc. has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its drug olezarsen, intended as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (sHTG). The designation is based on Phase 3 CORE and CORE2 studies, which showed olezarsen significantly reduced triglyceride levels and acute pancreatitis events compared to placebo. Ionis plans to submit a supplemental new drug application to the FDA by the end of the year. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ionis Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251201197223) on December 01, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
