Alnylam Pharmaceuticals said Monday that its treatment for an increasingly common heart condition cut the risk of death and recurrent cardiovascular complications in a key Phase 3 study, paving the way for the likely approval of the drug.
Specifically, on that composite primary endpoint, the drug, called vutrisiran, reduced the risk by 28% compared with placebo in the overall trial population, which included some people who were already taking a treatment for the disease considered the standard of care. In a subpopulation of patients who were not taking that background treatment, also known as the monotherapy population, vutrisiran cut the risk by 33% versus placebo.
Additionally, vutrisiran cut the risk of all-cause death, a secondary endpoint, by 36% in the overall population and 35% in the monotherapy group. This outcome included up to six months of data from an open-label extension that followed the blinded period of the trial.
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