Ionis Pharmaceuticals' (IONS) Tryngolza, used with diet, received approval from the US Food and Drug Administration to reduce triglycerides and the risk of acute pancreatitis in adult patients with severe hypertriglyceridemia, the agency said Wednesday.
Tryngolza received Priority Review and Breakthrough Therapy designations from the FDA for this indication, and the approval was granted to Ionis, according to a statement. Severe hypertriglyceridemia is a serious condition with fasting triglyceride levels of at least 500 mg/dL.
The approval is founded on efficacy and safety data from two trials in a total of 1,061 patients, which showcased that the rate of acute pancreatitis was reduced compared with the placebo group, according to the FDA.
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