Posted by Michael Wonder on 02 Dec 2025
Ionis receives US FDA breakthrough therapy designation for olezarsen for severe hypertriglyceridaemia
1 December 2025 - On track to submit supplemental new drug application by end of year.
Ionis Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to olezarsen as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia (triglyceride level greater than or equal to 500 mg/dL).
