- AMVUTTRA® (vutrisiran) shows significant reduction in mortality and cardiovascular events in ATTR amyloidosis with cardiomyopathy patients.
- HELIOS-B study results indicate 33% reduction in cardiovascular mortality and 36% reduction in all-cause mortality over 42 months.
- Alnylam Pharmaceuticals' (ALNY, Financial) findings presented at Heart Failure 2025 Congress, underscoring the rapid and sustained benefits of vutrisiran.
Alnylam Pharmaceuticals, Inc. (ALNY), a leader in RNAi therapeutics, reported significant findings from the HELIOS-B Phase 3 study, demonstrating the effectiveness of AMVUTTRA® (vutrisiran) in treating patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Presented at the Heart Failure 2025 Congress, the analysis highlights a substantial reduction in cardiovascular mortality and all-cause mortality among patients treated with vutrisiran.
The HELIOS-B study's 42-month data reveal a 36% reduction in the risk of all-cause mortality (HR: 0.64; p = 0.007) and a 33% reduction in cardiovascular mortality risk (HR: 0.67; p = 0.038) compared to placebo. Additionally, the data showed a 46% reduction in urgent heart failure visits (RR: 0.54; p = 0.041) and a 33% decrease in heart failure hospitalizations (RR: 0.67; p = 0.002) over 36 months.
These results, simultaneously published in the JACC, demonstrate the potent efficacy of vutrisiran in improving clinical outcomes for ATTR-CM patients, marking it as a differentiated first-line treatment option. The findings are considered robust due to the extensive patient follow-up, with data collected from over 99% of the randomized patients in the HELIOS-B study.
Further discussions at the Heart Failure 2025 Congress included details about the upcoming TRITON-CM Phase 3 study, which will evaluate the investigational TTR silencer, nucresiran, in patients with ATTR-CM. With plans to initiate this study in the first half of 2025, Alnylam aims to continue its trajectory in delivering transformative medicines for both rare and prevalent diseases through sustainable innovation.