WASHINGTON (dpa-AFX) - Alnylam Pharmaceuticals Inc. (ALNY) announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.
The approval expands the indication for AMVUTTRA, which now becomes the first and only therapeutic approved by the FDA for the treatment of ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Alnylam said it offers multiple programs to support broad and seamless patient access; Majority of Patients is expected to Pay $0 in Out-of-Pocket costs for AMVUTTRA.
The latest FDA approval is based on the HELIOS-B Phase 3 clinical trial which evaluated AMVUTTRA for the treatment of ATTR-CM. The trial achieved statistical significance compared to placebo on all 10 pre-specified primary and secondary endpoints.
According to the company, Marketing authorization applications based on HELIOS-B data are currently under review by several global health agencies including the European Medicines Agency (EMA), the Brazilian Health Regulatory Agency (ANVISA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Alnylam remains on track to proceed with additional global regulatory submissions for vutrisiran in 2025.
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