Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) announced that Australia's Therapeutic Goods Administration approved REDEMPLO (plozasiran) for treating familial chylomicronemia syndrome in adult patients.

REDEMPLO becomes the first medicine approved in Australia for treating FCS, a rare disease affecting an estimated 1 to 13 people per million globally. The condition causes extremely high triglyceride levels and increases the risk of acute pancreatitis.

The approval covers both genetically confirmed and clinically diagnosed adult patients with FCS for whom standard triglyceride lowering therapies have been inadequate. The drug is administered as a subcutaneous injection once every three months.

Australia's approval follows previous approvals in the United States, Canada, and China. The European Medicines Agency has issued a positive opinion recommending marketing authorization.

The TGA approval was based on results from the Phase 3 PALISADE study involving 75 subjects across 39 global sites. In the trial, 25 mg REDEMPLO reduced triglycerides by a median of 80% from baseline compared to a 17% reduction with placebo. The study also showed 83% lower odds of acute pancreatitis in the combined dose groups compared to placebo.

The most common adverse reaction reported was hyperglycaemia at 12.8%, according to the Australian Product Information. Other common side effects included headache, nausea, and injection site reactions.

REDEMPLO is designed to silence mRNA encoding apolipoprotein C-III, a protein that regulates triglyceride metabolism. The drug received priority review from Australia's TGA and has been granted Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA.

Arrowhead is also investigating plozasiran in additional Phase 3 studies for severe hypertriglyceridemia and hypertriglyceridemia conditions.