AMVUTTRA (vutrisiran sodium) is a transthyretin-directed small interfering RNA indicated for the treatment of adult patients with transthyretin-mediated amyloidosis. It is used to treat the polyneuropathy associated with the hereditary form of the disease. Additionally, it is indicated for the treatment of cardiomyopathy in both wild-type and hereditary forms to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits.
How AMVUTTRA Works
Vutrisiran is a double-stranded siRNA-GalNAc conjugate that functions through RNA interference to cause the degradation of mutant and wild-type transthyretin (TTR) messenger RNA. By targeting this messenger RNA, the drug reduces the production of serum TTR protein. This reduction in protein levels subsequently limits the formation of TTR protein deposits in body tissues.
Details
- Status
- Prescription
- First Approved
- 2022-06-13
- Patent Cliff
- 2036
- Revenue
- $827M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
AMVUTTRA Approval History
What AMVUTTRA Treats
2 indicationsAMVUTTRA is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Transthyretin-Mediated Amyloidosis
- Cardiomyopathy
AMVUTTRA Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMVUTTRA FDA Label Details
Indications & Usage
FDA Label (PDF)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. 1.2 Cardiomyopathy of Wild-type or Here...
AMVUTTRA Patents & Exclusivity
Patents (13 active)
Exclusivity
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Deep insights for AMVUTTRA
Revenue Insights
- • Q4-2025: $827M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 13 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.