Alnylam Eyes FDA Nod to Broaden Amvuttra’s Reach

Alnylam Pharmaceuticals (NASDAQ: ALNY) is poised for a significant milestone, with the U.S. Food and Drug Administration expected to approve an expanded use of its RNA interference (RNAi) therapy, Amvuttra (vutrisiran), for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) by March 23. If approved, Amvuttra would become the first RNAi therapy available for both ATTR-CM and hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN).

Visible Alpha consensus estimates project $445 million in 2025 revenue from the Amvuttra’s new indication, while Amvuttra for hATTR-PN is on track to achieve blockbuster status, with projected total sales of $1.5 billion in 2025. This brings the total sales for Alnylam’s ATTR franchise in 2025 to $2 billion.

The approval could drive substantial revenue growth for Alnylam. In 2024, Amvuttra for hATTR-PN generated $970 million in revenue, contributing to Alnylam’s +23% year-over-year product revenue increase to $2.2 billion. Analysts expect total product revenues to reach $2.9 billion in 2025, a +29% jump, with Amvuttra’s expansion playing a key role.