On November 21 2025, the UK National Institute for Health and Care Excellence (NICE) issued a final draft recommendation for Alnylam Pharmaceuticals’ RNA‑interference therapy AMVUTTRA (vutrisiran) to treat transthyretin amyloidosis‑related heart disease (ATTR‑CM) in England and Wales. The recommendation means the drug will be listed on the NHS formulary, giving patients in the two jurisdictions access through the public health system.
The decision opens a market of roughly 1,500 patients who could benefit from AMVUTTRA, a figure that underscores the commercial significance of the approval for Alnylam’s growth strategy. The drug’s inclusion in the NHS formulary is expected to accelerate uptake in the UK, complementing the company’s strong launch in the United States and its broader plan to expand the AMVUTTRA franchise worldwide.
Alnylam’s Q3 2025 financial results illustrate the commercial momentum behind the drug. Total revenue rose to $1.25 billion, a 149% year‑over‑year increase from $500.9 million in Q3 2024. AMVUTTRA alone generated $685 million, up 165% from the same period last year. CEO Yvonne Greenstreet highlighted the achievement, saying the quarter’s performance “underscores our ability to consistently deliver innovative medicines to patients around the world.” She added that the ATTR‑CM launch trajectory has prompted a new full‑year revenue guidance of $2.95 billion to $3.05 billion.
The UK approval comes at a time when the competitive landscape for ATTR‑CM is evolving. Pfizer’s Vyndaqel (tafamidis) is already used by the NHS, and NICE guidance indicates that the NHS will select the least expensive option after discussing benefits and risks with patients. AMVUTTRA’s mechanism—reducing transthyretin production at the source—offers a distinct therapeutic approach that could influence payer and provider decisions.
Regulatory milestones have built momentum for AMVUTTRA. The drug received EU approval for hereditary transthyretin amyloidosis with polyneuropathy in 2023, and the European Commission expanded the label for ATTR‑CM in June 2025. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved AMVUTTRA for ATTR‑CM in July 2025, and the U.S. FDA granted approval in March 2025. The NICE recommendation extends the drug’s reach to a new patient population in the UK.
The recommendation is a key driver for Alnylam’s global expansion strategy. By securing NHS access, the company can tap into a sizable patient base, reinforce its market position in the ATTR space, and support the upward revision of its 2025 revenue outlook. The event signals strong confidence from a major payer and reinforces the commercial viability of AMVUTTRA as a cornerstone of Alnylam’s portfolio.
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