– REDEMPLO is the first and only medicine approved for use in the treatment of FCS in Australia, and is authorized for both genetically confirmed and clinically diagnosed adult patients with FCS

– People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life

– The approval in Australia is based on positive results from the Phase 3 PALISADE study where REDEMPLO reduced triglycerides by a median of 80% from baseline and significantly reduced the incidence of acute pancreatitis across pooled doses, as compared with those using placebo

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) today announced that the Australian Therapeutic Goods Administration (TGA) has approved REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate. FCS is a severe, rare disease characterized by triglyceride levels that can be orders of magnitude higher than normal, leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. FCS remains widely underdiagnosed and affects an estimated 1 to 13 people per million globally.

REDEMPLO is the first and only medicine approved for use in the treatment of FCS in Australia, and is authorized for both genetically confirmed and clinically diagnosed adult patients with FCS. This approval by TGA follows approvals in the United States, Canada, and China, and a positive opinion recommending marketing authorization from EMA as Arrowhead continues its efforts to increase global access to care for people living with FCS.