BridgeBio's Acoramidis Nears FDA Approval, Competing with Pfizer and Emerging Therapies in ATTR-CM Treatment Market

BridgeBio Pharmaceuticals is on the brink of a significant advancement with its TTR stabilizer acoramidis, as the FDA decision date of November 29 approaches. In recent clinical assessments, acoramidis demonstrated a promising reduction in all-cause mortality by 36% and 34% at 36 and 42-month benchmarks, respectively, compared to placebo, while also significantly reducing the composite endpoint of all-cause mortality and recurrent cardiovascular-related hospitalizations by 46% and 48%[1][2]. These results bolster its potential market entry alongside Pfizer's tafamidis, the current frontrunner in the ATTR-CM market, despite concerns regarding acoramidis' dosing frequency and exclusion of a cardiovascular mortality benefit from its labeling. With acoramidis achieving stronger stabilization of the TTR protein compared to tafamidis, experts anticipate its approval could ignite fierce competition, further compounded by emerging RNA and gene therapy contenders such as Alnylam's Amvuttra and Intellia's next-generation treatments[1][2].