The FDA has approved BridgeBio Pharma’s acoramidis, branded as Attruby, for transthyretin amyloidosis cardiomyopathy (ATTR-CM), positioning the oral therapy to compete head-to-head with Pfizer’s tafamidis franchise (Vyndamax/Vyndaqel/Vynmac). According to PharmaPhorum.com, Attruby is indicated to reduce cardiovascular death and cardiovascular-related hospitalizations in adults with ATTR-CM, a progressive condition marked by transthyretin (TTR) protein misfolding and amyloid fibril deposits in the heart that drive heart failure and mortality.
Both acoramidis and tafamidis work by stabilizing the TTR protein to slow disease progression. BridgeBio highlights a key differentiator as it prepares for launch: it says Attruby is the only therapy with labeling that states it can achieve “near-complete stabilisation of TTR.” The company set a list price of $18,759 for a 28-day supply—roughly in line with the average annual cost of Pfizer’s products at about $225,000 before discounts and rebates. BridgeBio also committed to provide Attruby free for life to patients who participated in its clinical trials.
Regulatory clearance was supported by the ATTRibute-CM trial, in which Attruby achieved a 42% reduction in a composite of all-cause mortality and recurrent cardiovascular-related hospitalizations versus placebo at 30 months. With that efficacy profile and competitive pricing, analysts project meaningful uptake: consensus points to peak sales of $2 billion or more, with some estimates as high as $4 billion annually.
Pfizer’s tafamidis range, which has led the ATTR-CM market since its 2019 approval and is also used in ATTR polyneuropathy (ATTR-PN), generated $3.9 billion in the first nine months of this year, up two-thirds from the same period in 2023. However, it is entering the final years of patent life, potentially opening room for new entrants.
Competition is widening beyond oral stabilizers. Alnylam’s vutrisiran, a physician-administered subcutaneous injection given every three months, is seeking ATTR-CM approval next year, and Goldman Sachs has projected peak sales of $5 billion. AstraZeneca and Ionis’ eplontersen is another contender; both vutrisiran (Amvuttra) and eplontersen (Wainua) already have approvals in ATTR-PN.
BridgeBio is advancing a global rollout. It has filed in Europe, with a decision expected next year, and plans submissions in Japan and Brazil. To support commercialization, Bayer licensed European rights for $310 million in upfront and near-term payments, with BridgeBio eligible for royalties in the “low-thirties” percent range. AstraZeneca has licensed the drug for Japan. Earlier this year, BridgeBio monetized part of its future revenue stream via a $500 million deal to sell a 5% share of royalties that became payable upon FDA approval.
With compelling trial data, competitive pricing, and strategic partnerships, Attruby’s arrival sets the stage for a high-stakes reshaping of the ATTR-CM landscape.
