FDA approves Ionis’ Tryngolza

The US Food and Drug Administration (FDA) has 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 (AP).

News of the approval late yesterday pushed the shares of the drug’s developer, Ionis Pharmaceuticals (Nasdaq: IONS), up 11.7% to $39.75 in pre-market activity today.

Ionis noted that 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 (≤20 grams of fat per day). Tryngolza is self-administered via an auto-injector once monthly.