Alnylam Pharmaceuticals Inc. has secured expanded US approval for its heart drug Amvuttra, which could be the company’s biggest victory yet in its 23-year history. The approval is significant as it treats transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive disease affecting the heart.
The condition affects approximately 5,000 to 7,000 people annually in the US, but many remain undetected due to lack of awareness. With this new approval, Amvuttra will be available to treat ATTR-CM, with an expected list price of $470,000 a year. This is higher than competitors Pfizer’s Vyndamax and BridgeBio’s Attruby, at $270,000 and $225,000 respectively.
The broader label for Amvuttra includes reduced death rates, hospitalizations, and urgent heart failure visits. Analysts believe this could give Alnylam an edge over its competitors, particularly in front-line treatment scenarios. While Pfizer dominates the market with sales of around $5 billion annually, BridgeBio’s Attruby has also secured approval.
Alnylam will initially focus on treating newly diagnosed patients with the condition, and CEO Yvonne Greenstreet expects the company to find new patients quickly. However, competitors are taking steps to secure market share, including Pfizer’s training sessions for sales forces and analysts’ concerns about Alnylam’s pricing and competition from established products.
The approval of Amvuttra puts Alnylam on track to meet its 2025 guidance and potentially lift product sales to $5 billion by 2030. Nevertheless, analysts warn that the company faces significant challenges due to Pfizer’s strong market position and Alnylam’s higher list price.
Source: https://finance.yahoo.com/news/alnylam-heart-drug-approval-sets-133415474.html