Calls grow for side-by-side comparisons of ATTR-CM drugs
Clinicians and policy researchers are pressing for independent comparisons of the three approved ATTR-CM treatments, arguing that each company's product-by-product messaging leaves patients without a clear view of their options.
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Clinicians and policy researchers are pressing for independent comparisons of the three approved ATTR-CM treatments, arguing that each company's product-by-product messaging leaves patients without a clear view of their options.
No randomized trial has compared the drugs head to head. The Institute for Clinical and Economic Review recommended comparative effectiveness research on all three in similar populations when it published its final report in 2024.
In the meantime, observational data is filling part of the gap. BridgeBio has published a US claims analysis linking Attruby to a 34% lower risk of clinical worsening than tafamidis. Alnylam points to its HELIOS-B results, while Pfizer emphasizes its longer track record.
The FDA has issued guidance on the use of claims and health-record data, which can show active-treatment comparisons but carry risks of bias.
Proponents say a standard patient summary covering route, dosing, approved use, trial results and uncertainties would make unsupported superlatives easier to spot. Researchers point to established methodology standards for such comparisons.