(RTTNews) - Ionis Pharmaceuticals Inc. (IONS) announced that the U.S. Food and Drug Administration approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis.
TRYNGOLZA is the first-ever FDA-approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides clinically meaningful reduction in AP events when used with an appropriate diet (less than or equal to 20 grams of fat per day. TRYNGOLZA is self-administered via an auto-injector once monthly.
The FDA approval was based on positive data from the Phase 3 Balance clinical trial in adult patients with genetically identified FCS and fasting triglyceride levels greater than or equal to 880 mg/dL. In the Balance study, TRYNGOLZA 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months (p=0.0084). Reductions from baseline to 12 months were further improved, with TRYNGOLZA achieving a placebo-adjusted 57% mean reduction in triglycerides.
TRYNGOLZA will be available in the U.S. before year end.
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