Alnylam Eyes Expansion into ATTR-CM Market with Amvuttra, Projecting Strong Growth

Alnylam Pharmaceuticals is poised for a potential market expansion as it awaits the FDA's decision on Amvuttra for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). With the decision date set for March 23, the company is optimistic about its prospects in this increasingly competitive indication.

Amvuttra's Market Potential

Tolga Tanguler, Alnylam's chief commercial officer, emphasized the growth opportunities in the ATTR-CM market during a recent conference call. "The category is rapidly growing and it's been largely underserved," Tanguler stated. "This will be a market-growth story."

Alnylam projects combined sales of Onpattro and Amvuttra to reach between $1.6 billion and $1.7 billion in 2025, building on the ATTR franchise's 2024 sales of $1.23 billion. Notably, Amvuttra nearly achieved blockbuster status in just its second full year on the market, with sales of $970 million.

Competitive Landscape and Market Dynamics

The potential expansion into ATTR-CM would position Amvuttra as a direct competitor to established treatments. Tanguler highlighted the uniqueness of their offering, stating, "Assuming approval, Amvuttra would be the first and only RNAi approved for both ATTR-CM and hATTR-PN."

This move comes as other players enter the field. BridgeBio recently received FDA approval for Attruby, its transthyretin stabilizer, which is set to challenge Pfizer's Vyndaqel franchise in the ATTR-CM market.

Financial Outlook and Growth Projections

Alnylam reported strong financial performance, with net product revenue of $451 million in the fourth quarter of 2024, marking a 30% increase year over year. Looking ahead, the company projects product revenue between $2.05 billion to $2.25 billion for 2025, representing a potential 31% increase at the midpoint.

The anticipated expansion into ATTR-CM, while not expected to contribute significantly to the top line in 2025, is viewed as a promising long-term opportunity for Alnylam. As the company prepares for this potential new chapter, it continues to build on the success of its existing ATTR franchise, which has shown robust growth in recent years.