Congratulations to Alnylam Pharmaceuticals on the FDA Approval of Amvuttra.

December 16, 2025 · Alnylam Canada

Health Canada Approves AMVUTTRA (vutrisiran) for ATTR Cardiomyopathy

Health Canada has authorized AMVUTTRA for the treatment of cardiomyopathy in adults with wild-type or hereditary transthyretin-mediated (ATTR) amyloidosis.

• The approval broadens AMVUTTRA's Canadian indication, which already covered stage 1 or stage 2 polyneuropathy in adults with hereditary ATTR amyloidosis
• Based on the Phase 3 HELIOS-B trial, in which AMVUTTRA reduced the risk of all-cause mortality and recurrent cardiovascular events by 28.2% in the overall population and 32.8% in the monotherapy population, compared with placebo
• Adverse events in HELIOS-B were similar in nature, frequency, and severity to placebo
• Alnylam Canada says its next priority is working with provinces and private payers on patient access

Read the full release

Source: Alnylam Canada ULC, via Canada Newswire and BioSpace. Regulatory approval does not guarantee public or private reimbursement. Approved indications vary by country; consult the Canadian product monograph for full prescribing and safety information.