EU approves Arrowhead's plozasiran for rare triglyceride disorder

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that the European Commission has granted marketing authorization for REDEMPLO (plozasiran) to reduce triglyceride levels in adults with familial chylomicronemia syndrome (FCS), a rare disease characterized by extremely high triglyceride levels that can lead to acute pancreatitis and other serious complications.

The authorization covers patients diagnosed either by clinical criteria or genetic testing. The European Medicines Agency noted that while other authorized medicines exist for FCS confirmed by genetic testing, REDEMPLO does not require genetic confirmation, expanding the eligible patient population.

The approval is supported by data from the Phase 3 PALISADE study, a randomized, double-blind, placebo-controlled trial in 75 adults with FCS. In the study, the 25 mg dose of plozasiran reduced triglycerides by a median of 80% from baseline, compared with a 17% reduction in the placebo group. A pooled analysis of patients receiving all doses showed an 83% lower odds of acute pancreatitis compared with placebo. The most common adverse reactions reported were hyperglycemia (12.8%), headache (6.8%), nausea (4.7%), and injection site reaction (4.7%).

REDEMPLO is administered via subcutaneous injection once every three months and works by suppressing production of apolipoprotein C-III, a liver protein that raises triglyceride levels. The drug has previously received approval from the U.S. Food and Drug Administration, Health Canada, China's National Medical Products Administration, and the Australian Therapeutic Goods Administration for the same indication.

Arrowhead stated it is engaging with national authorities and healthcare communities across the European Union to make the treatment available. Plozasiran is also being studied in separate Phase 3 trials for adults with severe hypertriglyceridemia.

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