Amvuttra Availability Timeline
Amvuttra (vutrisiran) has been available since June 2022, when it received FDA approval in the United States for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults 1.
Regulatory Approval History
- June 2022: FDA approved vutrisiran in the United States for hATTR amyloidosis with polyneuropathy 1
- July 2022: Received positive opinion in the European Union for hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy 1
- March 2025: Most recently approved by FDA for ATTR-CM (cardiac amyloidosis), making it one of the latest additions to available ATTR-CM treatments alongside tafamidis and acoramidis 2
Clinical Context
Vutrisiran represents one of three FDA-approved TTR silencers for ATTRv polyneuropathy, alongside patisiran and inotersen 3. The medication is administered subcutaneously at 25 mg every 3 months, offering a convenient dosing schedule compared to other TTR silencers 3, 4.
The approval was based on the HELIOS-A phase 3 trial, which demonstrated significant improvements in neuropathy impairment scores, quality of life measures, gait speed, nutritional status, and disability scores compared to external placebo 5. The American College of Cardiology emphasizes that early treatment with vutrisiran produces superior outcomes compared to delayed therapy 6.
Important Clinical Considerations
- Vitamin A supplementation (3,000 IU daily) is required with vutrisiran due to reduced retinol transport 3, 6
- The medication was generally well tolerated in clinical trials, with the most common adverse events being pain in extremity and arthralgia 4
- Vutrisiran has been available for approximately 2.5-3 years as of early 2025 1