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# Alnylam Pharma Amyloidosis Therapy Approved
- URL: https://www.fdaweb.com/alnylam-pharma-amyloidosis-therapy-approved/
- Published: 2022-06-14T12:00:00.000Z
- Updated: 2026-09-14T17:48:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152057

FDA has approved an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three months for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Approval was based on nine-month data from the HELIOS-A Phase 3 study that showed the therapy significantly improved the signs and symptoms of polyneuropathy, with more than 50% of patients experiencing a halting or reversal of their disease manifestations, according to the company.

Regarding safety, the company says Amvuttra showed an “encouraging” safety and tolerability profile for nine months of dosing, and there were no drug-related discontinuations or deaths. The most common adverse events included arthralgia (11%), dyspnea (7%) and decreased vitamin A (7%).