Alnylam to present additional data for patisiran in patients with the cardiomyopathy of ATTR amyloidosis, including 24-month results from the APOLLO-B phase III study, at the Heart Failure Society of America Annual Scientific Meeting 2023.

Data from an interim analysis of the ongoing open-label extension (OLE) period of the APOLLO-B Phase III study of patisiran in patients with the cardiomyopathy of ATTR amyloidosis through 24 months will be presented. In addition, findings from a post-hoc analysis of the APOLLO-B Phase III study that further characterize the impact of patisiran on health status and quality of life in patients with the cardiomyopathy of ATTR amyloidosis will be presented, as well as demographics, baseline characteristics and safety data for patients who enrolled in the expanded access program (EAP) for patisiran.

HFSA Presentation Details :i. "Baseline Characteristics of Patients with Transthyretin Cardiac Amyloidosis Enrolled in the Patisiran Expanded Access Program"- Poster 087: General ePoster Viewing Session 1,Friday, October 6, 2023, 7:00 – 7:30 p.m. ET, Presenting Author: Naveen Saha. ii "Primary Results from APOLLO-B Open-label Extension Study of Patisiran in Patients with Transthyretin Cardiac Amyloidosis"- Poster 021: Oral Abstract Session 4 Saturday, October 7, 2023, 5:21 – 5:31 p.m. ET. Presenting Author: Mathew Maurer. iii, "Impact of Patisiran on Health Status and Quality of Life in Patients with Transthyretin Cardiac Amyloidosis"- Poster 030: Oral Abstract Session 6, Sunday, October 8, 2023, 8:24 – 8:34 a.m. ET, Presenting Author: Parag Kale.

As previously announced, a supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis is under review by the FDA, with an action date of October 8, 2023 under the Prescription Drug User Fee Act (PDUFA). Patisiran is the established name for Onpattro , which is approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.