The Latest Cardiac and Vascular News
– PDUFA Date Set for October 8, 2023 – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the […]
– sNDA Submission is Based on Findings from the APOLLO-B Phase 3 Study That Showed Patisiran Demonstrated Significant Improvement on Functional Capacity, Health Status and Quality of Life Compared to Placebo at Month 12 – – Study Also Demonstrated Encouraging Safety Profile in Patients with Cardiomyopathy of ATTR Amyloidosis – […]
− Phase 3b Open-Label Study Showed Treatment with Patisiran Achieved Rapid and Sustained Reduction in Serum TTR Levels in hATTR Amyloidosis Patients with Polyneuropathy Progression Following Orthotopic Liver Transplant – − Additional Results from Pre-specified Patient Subgroups Analysis Included with Encore Presentation of HELIOS-A Phase 3 Study of Investigational Vutrisiran […]
− APOLLO-B is the Industry’s Furthest Progressed Randomized, Double-Blind, Placebo-Controlled Pivotal Study of an Investigational TTR Silencer in Hereditary and Wild-type ATTR Amyloidosis with Cardiomyopathy − − Topline Results Expected in Mid-2022 − CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has achieved […]
