Ionis Pharmaceuticals Receives FDA Approval for TRYNGOLZA to Treat Severe Hypertriglyceridaemia
Ionis Pharmaceuticals has received US Food and Drug Administration (FDA) approval for TRYNGOLZA® (olezarsen) as an adjunct to diet for adults with severe hypertriglyceridaemia (sHTG), defined as triglyceride levels of 500 mg/dL or higher.
The therapy is approved to reduce triglyceride levels and lower the risk of acute pancreatitis, a serious complication associated with the condition.
TRYNGOLZA is available in 50 mg and 80 mg doses and is administered once a month using a self-injection autoinjector.
The approval is based on positive findings from the Phase III CORE and CORE2 clinical trials, which evaluated the therapy in adults with severe hypertriglyceridaemia receiving standard care.
In the studies, TRYNGOLZA reduced fasting triglyceride levels by up to 72 per cent compared with placebo after six months, with sustained improvements over one year.
The treatment also reduced acute pancreatitis events by up to 91 per cent. In addition, 86 per cent of treated patients achieved triglyceride levels below 500 mg/dL after 12 months.
The therapy demonstrated a favourable safety profile, with injection site reactions and elevated liver enzymes reported as the most common adverse events.
Ionis plans to launch TRYNGOLZA in the United States during July. The medicine is also approved for treating familial chylomicronaemia syndrome, a rare inherited form of severe hypertriglyceridaemia.
