Alnylam announced that Canada’s Drug Agency (CDA) has issued a positive recommendation for public reimbursement of its RNAi therapeutic AMVUTTRA (vutrisiran injection) for the treatment of cardiomyopathy in adult patients with wild‑type or hereditary transthyretin‑mediated amyloidosis (wtATTR or hATTR). The recommendation, issued by CADTH in February 2026, includes conditions that the drug’s cost must not exceed that of tafamidis and that patients meet specific eligibility criteria.
The recommendation follows Health Canada’s December 2025 approval of AMVUTTRA for the same indication and the agency’s earlier December 2023 recommendation for the polyneuropathy indication. Prior to this, AMVUTTRA was only authorized for sale in Canada for hereditary transthyretin‑mediated amyloidosis polyneuropathy. The new recommendation expands access to the cardiomyopathy indication, potentially increasing patient uptake and revenue for Alnylam’s ATTR franchise.
Alnylam’s management highlighted the significance of the decision. Country General Manager Colleen Coxson said the recommendation “brings us one step closer to delivering access to a first‑in‑class treatment that targets the root cause of the disease.” She added that the expanded treatment landscape will help preserve function, enhance quality of life, and support longer survival for patients.
The recommendation is expected to strengthen Alnylam’s competitive position against tafamidis, the current standard of care in Canada. By meeting the cost parity condition, AMVUTTRA can be offered to patients who would otherwise face higher out‑of‑pocket expenses, potentially shifting market share in the ATTR‑CM segment.
Alnylam’s recent financial results underscore the commercial momentum behind AMVUTTRA. In Q4 2025, the company reported total revenues of $1.10 billion, up 85% year‑over‑year, and net product revenues for its TTR franchise of $858 million, a 151% increase from Q4 2024. The strong growth reflects robust demand for ATTR therapies and the company’s expanding product portfolio.
While the article does not provide specific revenue projections for the new reimbursement, the expanded access is likely to translate into higher sales volumes for AMVUTTRA’s cardiomyopathy indication, reinforcing Alnylam’s revenue trajectory and supporting its broader strategy of durable leadership in the ATTR market.
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