BridgeBio’s Attruby Gains FDA Approval, Challenging Pfizer’s Tafamidis in ATTR-CM Treatment

The FDA approved BridgeBio's Attruby (acoramidis) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults18.

Attruby is indicated to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients8.

BridgeBio claims Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR (≥90%)58.

Attruby will compete directly with Pfizer's established tafamidis (Vyndaqel/Vyndamax) in the ATTR-CM market15.

BridgeBio has priced Attruby at approximately $244,500 per year, slightly higher than tafamidis5.

Early commercial progress shows 430 Attruby prescriptions written by 248 unique healthcare providers since FDA approval10.

The ATTR-CM market was valued at $5.2 billion in 2023 and is expected to grow to $9.4 billion by 20315.

BridgeBio has submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 20258.

The company has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe8.

Despite new treatments, ATTR-CM patients still face high mortality rates, with studies showing 40% mortality within 4 years even with tafamidis treatment3.

Sources:

1. https://www.fiercepharma.com/pharma/comeback-story-bridgebio-scores-fda-nod-cardiomyopathy-set-take-pfizer

3. https://www.tctmd.com/news/even-tafamidis-attr-cm-patients-face-high-mortality-over-time

5. https://www.biospace.com/drug-development/attr-cm-approval-for-bridgebio-could-trigger-tight-race-with-pfizer

8. https://bridgebio.com/news/attruby-acoramidis-a-near-complete-ttr-stabilizer-%E2%89%A590-approved-by-fda-to-reduce-cardiovascular-death-and-cardiovascular-related-hospitalization-in-attr-cm-patients/

10. https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-announces-commercial-progress-program-updates-and-2025

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