Plozasiran PDUFA Date (Arrowhead Pharmaceuticals)
FDA PDUFA decision date for Plozasiran is November 18, 2025. Developed by Arrowhead Pharmaceuticals. Indication: Familial chylomicronemia syndrome (FCS). Current status: Approved.
Indication
Familial chylomicronemia syndrome (FCS)
Regulatory details
- Company: Arrowhead Pharmaceuticals
- Therapeutic area: Rare Disease / Metabolic
- Application type: NDA
- Review type: Priority
- PDUFA date: 2025-11-18
- Outcome: Approved