Treats polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN). NDA 215515, held by Alnylam Pharms Inc. Vutrisiran Sodium.
As of Nov 14, 2026, NDA 215515 (Amvuttra), held by Alnylam Pharms Inc, was first approved by FDA on Jun 13, 2022, with 3 approved supplements and 0 published complete response letters.
AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of: the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits 1.1 Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. 1.
| Mar 20, 2025 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AmvuttraEQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) · solution;subcutaneous | Vutrisiran Sodium | RxReference drug |
| Mar 20, 2025 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 11, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Feb 16, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Jun 13, 2022 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
