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FDA Approves BridgeBio's Attruby, Setting Up Competition with Pfizer's Vyndamax in ATTR-CM Market

• The FDA has approved BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a heart condition leading to heart failure and death. • Attruby demonstrated a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalizations compared to placebo in the ATTRibute-CM trial. • BridgeBio is launching Attruby at a list price of $18,759 for a 28-day supply, positioning it to compete with Pfizer's Vyndamax, which dominates the ATTR-CM market. • Several other companies, including Alnylam and AstraZeneca/Ionis, are also developing therapies for ATTR, potentially disrupting the current treatment landscape.

The FDA has approved BridgeBio Pharma's acoramidis, marketed as Attruby, for the treatment of transthyretin amyloidosis cardiomyopathy (ATTR-CM) in adults. This approval sets the stage for direct competition with Pfizer's established therapy, Vyndamax (tafamidis), in the ATTR-CM market.

Clinical Trial Results

The approval was based on the ATTRibute-CM trial, which demonstrated that Attruby significantly reduced the composite endpoint of all-cause mortality and recurrent cardiovascular-related hospitalizations by 42% compared to placebo over a 30-month period. This data underscores the potential of Attruby to improve outcomes for patients suffering from this life-threatening condition.

Mechanism of Action and Market Positioning

ATTR-CM is characterized by the accumulation of amyloid fibrils in the heart, leading to heart failure and death. Both Attruby and Vyndamax work by stabilizing the transthyretin (TTR) protein, preventing its misfolding and subsequent amyloid fibril formation. BridgeBio emphasizes that Attruby's label highlights its ability to achieve "near-complete stabilization of TTR."

Competitive Landscape

Pfizer's Vyndamax currently dominates the ATTR-CM market, with sales reaching $3.9 billion in the first nine months of 2023, a 66% increase compared to the same period in 2022. However, with patents nearing expiration, Pfizer's market share is potentially vulnerable. BridgeBio has priced Attruby at $18,759 for a 28-day supply, close to Vyndamax's average annual cost of $225,000 before discounts and rebates.

Future Developments

BridgeBio plans to pursue regulatory approvals for acoramidis in Europe, Japan, and Brazil. Other companies, including Alnylam with vutrisiran and AstraZeneca/Ionis with eplontersen, are also developing therapies for ATTR, potentially reshaping the treatment landscape. Analysts predict peak sales for Attruby could reach $2 billion or more, while Alnylam's vutrisiran is projected to reach $5 billion.
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Reference News

[1]
Deep Dive: Cardiovascular Disease Back in the Spotlight
biospace.com · Mar 10, 2025
[2]
Pfizer Mounts Defense of Cardiac Blockbuster as Alnylam, BridgeBio Enter Market
biospace.com · Apr 22, 2025
[3]
BridgeBio poised to challenge Pfizer after Attruby approval - Pharmaphorum
pharmaphorum.com · Apr 28, 2025

FDA approves BridgeBio Pharma's acoramidis (Attruby) for ATTR-CM, setting up a market competition with Pfizer's Vyndamax...

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