Amvuttra (vutrisiran) PDUFA Date (Alnylam Pharmaceuticals)
FDA PDUFA decision date for Amvuttra (vutrisiran) is March 23, 2025. Developed by Alnylam Pharmaceuticals. Indication: ATTR cardiomyopathy (ATTR-CM). Current status: Approved.
Indication
ATTR cardiomyopathy (ATTR-CM)
Regulatory details
- Company: Alnylam Pharmaceuticals
- Therapeutic area: Rare Disease / Cardiology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2025-03-23
- Outcome: Approved