FDA approves Ionis drug Tryngolza for severe hypertriglyceridemia

Ionis Pharmaceuticals (Nasdaq: IONS) announced that the U.S. Food and Drug Administration has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia, defined as triglyceride levels of 500 mg/dL or higher.

Tryngolza is available in 50 mg and 80 mg doses and is self-administered once monthly via an autoinjector. The drug is set to become available in the U.S. in July.

The FDA approval was based on results from the Phase 3 CORE and CORE2 studies, published in The New England Journal of Medicine. In those trials, Tryngolza reduced fasting triglyceride levels by up to 72% compared to placebo at six months. At 12 months, the drug reduced acute pancreatitis events by up to 91%. Among treated patients with baseline and 12-month data, 86% achieved triglyceride levels below 500 mg/dL.

The most common adverse reactions in patients with severe hypertriglyceridemia, occurring at an incidence at least 2% higher than placebo, were injection site reactions and liver enzyme increases. The drug is contraindicated in patients with a history of serious hypersensitivity to olezarsen or its excipients.

Tryngolza is also approved in the U.S., European Union, and other countries for adults with familial chylomicronemia syndrome, a rare form of severe hypertriglyceridemia. According to Ionis, more than 3 million people in the U.S. are living with severe hypertriglyceridemia, including approximately 1 million considered high risk.

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