---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-173444"
form_type: "8-K"
ticker: "ALNY"
cik: "0001178670"
company_name: "ALNYLAM PHARMACEUTICALS, INC."
filed_at: "2022-06-14T23:59:59+00:00"
generated_at: "2026-06-25T01:53:06.670308+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Alnylam gets FDA approval for AMVUTTRA (vutrisiran) for hATTR amyloidosis polyneuropathy

## Summary
- FDA approval based on HELIOS-A Phase 3: 17.0-point mean improvement in mNIS+7 vs placebo (p<0.0001); 50% of patients saw improvement.
- AMVUTTRA is first FDA-approved treatment for hATTR polyneuropathy with reversal of impairment; subcutaneous injection once every three months.
- Launch expected early July; value-based agreements to accelerate patient access.
- Under review by EMA, ANVISA, PMDA; HELIOS-B trial for cardiomyopathy ongoing.
- Most common adverse reactions: arthralgia (11%), dyspnea (7%), vitamin A decreased (7%).

## SEC filing metadata
- accession: 0001193125-22-173444
- form_type: 8-K
- ticker: ALNY
- cik: 0001178670
- company_name: ALNYLAM PHARMACEUTICALS, INC.
- filed_at: 2022-06-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1178670/000119312522173444/0001193125-22-173444-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1178670/000119312522173444/d518443d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-173444
- JSON: https://secwatch.observer/filing/0001193125-22-173444.json
- Plain text: https://secwatch.observer/filing/0001193125-22-173444.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.