Alnylam’s Amvuttra Wins FDA Approval, Challenges Pfizer in $11B Heart Drug Market

The U.S. Food and Drug Administration has approved Alnylam Pharmaceuticals’ drug Amvuttra to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and potentially fatal heart condition. The green light positions Alnylam to challenge Pfizer’s blockbuster drug Vyndaqel in a market projected to exceed $11 billion by 2032, according to Global Market Insights.

Amvuttra, chemically known as vutrisiran, was initially approved in 2022 for ATTR-related nerve damage. This expanded approval makes it the first therapy available to treat both nerve and cardiac manifestations of the disease. Unlike Vyndaqel and BridgeBio’s Attruby, which stabilize faulty transthyretin proteins, Amvuttra works by reducing production of the disease-causing protein at its source.

Alnylam aims to leverage this milestone to reach profitability and fund future innovations. “It’s going to help us get to profitability and help us invest in the next generation of molecules,” said Chief Medical Officer Pushkal Garg.

Pricing will be critical in gaining market share. For nerve damage, Amvuttra costs $119,351 per prefilled syringe and is administered quarterly. Alnylam confirmed the same price for treating ATTR-CM. In comparison, Attruby is priced at $18,759.12 per 28-day supply, while Vyndaqel costs approximately $268,000 annually.

Despite being an injectable therapy in a market with oral options, analysts project Amvuttra could generate nearly $5 billion in sales by 2029, according to LSEG. Alnylam will need to focus on strategic commercialization to attract patients to its new treatment.

Following the FDA announcement, Alnylam’s shares were temporarily halted in after-hours trading.