STAT+: Alnylam reports positive results for heart drug in pivotal study, likely clearing path to approval
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% 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%.
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.
