Alnylam Says Phase 3 HELIOS-B Study Of Vutrisiran Met Primary Goal

(RTTNews) - Alnylam Pharmaceuticals, Inc. (ALNY) Monday said its Phase 3 HELIOS-B study evaluating vutrisiran in Transthyretin amyloid cardiomyopathy (ATTR-CM) met primary goal.

In the study, patients with ATTR-CM were randomized to receive either vutrisiran or placebo for a period of up to 36 months. Results from the study showed statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular (CV) events in both the overall population and in the monotherapy population. Additionally, treatment with vutrisiran reduced all-cause mortality in the overall population and in the monotherapy population up to month 42.

Alnylam plans to file global regulatory submissions starting later this year including a supplmental New Drug Application to the FDA seeking priority review.