Alnylam Pharmaceuticals (Nasdaq: ALNY) presented five-year data from the HELIOS-B Phase 3 study at the American Heart Association Scientific Sessions 2026, showing that continuous treatment with AMVUTTRA (vutrisiran) was associated with lower rates of mortality and cardiovascular events compared with patients who initiated treatment approximately three years later.
In the monotherapy population of 395 patients not receiving tafamidis at baseline, continuous vutrisiran treatment was associated with a 48% lower risk of the composite of all-cause mortality and recurrent cardiovascular events compared with delayed treatment initiation (HR: 0.515; 95% CI: 0.368, 0.722; p=0.0001). In the overall population of 654 patients, the risk reduction was 41% (HR: 0.589; 95% CI: 0.459, 0.756; p<0.0001).
Patients who received continuous vutrisiran also showed better quality of life scores, as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary, and greater stability in cardiac biomarkers including NT-proBNP and troponin I. Among patients receiving tafamidis at baseline, adding vutrisiran continuously was associated with a 23% reduction in recurrent cardiovascular events compared with delayed addition of vutrisiran. No new safety signals were identified through 60 months.
A separate post hoc analysis of 48 patients who underwent cardiopulmonary exercise testing at the National Amyloidosis Centre in London showed that vutrisiran preserved peak oxygen uptake with an LS mean difference of 1.57 mL/kg/min versus placebo (95% CI: 0.14 to 3.00; p=0.031), along with favorable effects on chronotropic response, ventilatory efficiency, and measures of right and left ventricular function during stress echocardiography.
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