Olezarsen PDUFA Date (Ionis Pharmaceuticals)
FDA PDUFA decision date for Olezarsen is June 30, 2026. Developed by Ionis Pharmaceuticals. Indication: Severe hypertriglyceridemia. Current status: Approved.
Indication
Severe hypertriglyceridemia
Notes
First-in-class APOC3 antisense. Breakthrough therapy designation.
Regulatory details
- Company: Ionis Pharmaceuticals
- Therapeutic area: Metabolic / Cardiology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-06-30
- Outcome: Approved