Business Wire·May 1, 2026, 7:30 AM ET

Arrowhead Pharmaceuticals Receives TGA Approval of REDEMPLO® (plozasiran) in Australia, Expanding Global Access for Patients with Familial Chylomicronemia Syndrome (FCS)

The Australian Therapeutic Goods Administration (TGA) has approved REDEMPLO® (plozasiran) as the first & only medicine for treating familial chylomicronemia syndrome (FCS) in Australia.
REDEMPLO is authorized for adult patients with genetically confirmed or clinically diagnosed FCS as an adjunct to diet to reduce triglyceride levels.
Approval is based on positive Phase 3 PALISADE study results where REDEMPLO reduced triglycerides by a median of 80% from baseline compared to a 17% reduction with placebo.
The PALISADE study demonstrated an 83% lower incidence of acute pancreatitis in pooled dose groups (25 mg & 50 mg) versus the placebo group.
REDEMPLO utilizes Arrowhead's TRiM™ platform to silence mRNA encoding apolipoprotein C-III (apoC-III), a key regulator of triglyceride metabolism.
The medication is self-administered via subcutaneous injection once every three months.
Common adverse reactions include hyperglycaemia (12.8%), headache (6.8%), nausea (4.7%), & injection site reaction (4.7%).
This Australian approval follows previous authorizations in the United States, Canada, China, & a positive opinion from the European Medicines Agency (EMA).
FCS is a rare disease affecting an estimated 1 to 13 people per million globally, characterized by extremely high triglyceride levels & a high risk of pancreatitis.
REDEMPLO received Breakthrough Therapy, Fast Track, & Orphan Drug designations from the U.S. FDA, & Orphan Medicinal Product Designation from the EMA.