07:27 AM EDT, 09/19/2025 (MT Newswires) -- Ionis Pharmaceuticals ( IONS ) and Sobi said Friday that Tryngolza has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome.

The approval follows the positive opinion by the Committee for Medicinal Products for Human Use and "positive" data from a phase 3 study in which an 80 mg dosing showed "statistically significant" reduction in fasting triglyceride levels at six months that was sustained through 12 months, the company said.

The drug also showed "substantial and clinically meaningful" reduction in acute pancreatitis events over 12 months, the company said.

Familial chylomicronemia syndrome is a rare genetic form of severe hypertriglyceridemia, which heightens the risk of acute pancreatitis.

Sobi retains exclusive rights to commercialize Tryngolza outside the US, Canada, and China.