– If confirmed by the European Commission, REDEMPLO would be the first and only siRNA medicine authorized in the EU 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 CHMP opinion is based on positive results from the Phase 3 PALISADE study where REDEMPLO reduced triglycerides by a median of 80% from baseline and significantly fewer cases of acute pancreatitis were seen in patients using REDEMPLO compared with those using placebo

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has adopted a positive opinion, recommending the approval of REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). FCS remains widely underdiagnosed and affects an estimated 1 to 13 people per million globally. This rare disease is 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.

The European Commission is expected to issue a decision on REDEMPLO's Marketing Authorization in the second quarter of 2026. If approved, REDEMPLO will be the first and only siRNA medicine authorized in the European Union for both genetically confirmed and clinically diagnosed adult patients with FCS. This recommendation follows approvals in the United States, Canada, and China, as Arrowhead continues its efforts to increase global access to care for people living with FCS.