Arrowhead Pharmaceuticals announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for its RNA interference therapy REDEMPLO (plozasiran) as an adjunct to diet for adult patients with familial chylomicronemia syndrome (FCS). The decision makes REDEMPLO the first and only medicine approved in Australia for this rare disorder, which is characterized by extremely high triglyceride levels and a heightened risk of acute pancreatitis.
The approval was based on the Phase 3 PALISADE study, which demonstrated a median 80 % reduction in triglycerides and an 83 % lower odds of acute pancreatitis compared with placebo. These results confirm the clinical benefit of REDEMPLO and support its use as a disease‑modifying therapy for FCS.
REDEMPLO’s Australian approval follows similar regulatory approvals in the United States, Canada, and China, and a positive opinion from the European Medicines Agency issued on April 24 2026. The drug now expands global access for an estimated 1–13 patients per million worldwide, with about 6,500 confirmed cases in the United States alone.
The approval reinforces Arrowhead’s TRiM™ platform, validating its RNAi technology and supporting the company’s strategy to monetize its pipeline across multiple indications. Arrowhead is also investigating plozasiran in additional Phase 3 studies for severe hypertriglyceridemia, broadening the potential market for the therapy. In Q1 FY2026, Arrowhead reported a net income of $30.8 million, reflecting the company’s growing commercial momentum.
"We are pleased that REDEMPLO is now the first‑ever approved treatment for Australians living with genetic or clinical FCS. This approval underscores the strength of the clinical data and the ability of our TRiM™ platform to develop targeted siRNA therapies to potentially reach multiple tissues and disease areas. We believe REDEMPLO could represent an important medicine for the FCS community in Australia, and we are working to bring this therapy to more patients as quickly as possible," said Christopher Anzalone, Ph.D., President and CEO of Arrowhead Pharmaceuticals.
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