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The U.S. Food and Drug Administration (FDA) has approved Arrowhead Pharmaceuticals, Inc.’s (NASDAQ:ARWR) Redemplo (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
FCS is a rare, inherited metabolic disorder that causes extremely high levels of triglycerides (fat) in the blood due to a defective or missing enzyme called lipoprotein lipase.
FCS is characterized by triglyceride levels that can be 10 to 100 times higher than normal, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS.
Redemplo is the first and only FDA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months.
Redemplo utilizes the proprietary and differentiated Targeted RNAi Molecule (TRiM) platform and is Arrowhead’s first FDA-approved medicine, marking a major milestone for the company as it transitions into commercial-stage.
The FDA approval was supported by clinical data from the Phase 3 PALISADE study.
The PALISADE study met its primary endpoint and all multiplicity-controlled key secondary endpoints, including demonstrating significant reductions in triglycerides and APOC3.
In PALISADE, 25 mg Redemplo achieved deep and durable reductions in triglycerides, with a median change from baseline of -80% versus -17% in the pooled placebo group, and a lower numerical incidence of acute pancreatitis compared with placebo.
Redemplo will be available in the U.S. before the end of the year.
Price Action: ARWR stock was trading higher by 6.00% to $42.56 at last check Tuesday.
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