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Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)
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The U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), as announced by Arrowhead Pharmaceuticals, Inc.

FCS is a severe, rare genetic or clinical disease, affecting an estimated 6,500 people in the U.S., characterized by extremely high triglyceride levels—often 10 to 100 times normal—which leads to a substantially higher risk of acute, recurrent, and potentially fatal pancreatitis, significantly reducing patients' quality of life. FCS is a severe, rare genetic or clinical disease, affecting an estimated 6,500 people in the U.S., characterized by extremely high triglyceride levels—often 10 to 100 times normal—which leads to a substantially higher risk of acute, recurrent, and potentially fatal pancreatitis, significantly reducing patients' quality of life.

REDEMPLO is the first and only FDA-approved siRNA medicine for FCS and utilizes Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform. This approval marks a transformational milestone for Arrowhead, moving the company into the commercial stage with its first FDA-approved product.

The medicine can be conveniently self-administered at home via a simple subcutaneous injection once every three months. The FDA's decision was based on positive clinical data from the Phase 3 PALISADE study, a randomized, double-blind, placebo-controlled trial, which met its primary and all key secondary endpoints, demonstrating that 25 mg of REDEMPLO achieved deep and durable reductions in triglycerides, with a median change of 80% from baseline compared to 17% in the placebo group, and a lower numerical incidence of acute pancreatitis. Plozasiran works by suppressing the production of apolipoprotein C-III (apoC-III), a protein that raises triglyceride levels by hindering their breakdown and clearance. The most common adverse reactions experienced by REDEMPLO-treated patients were hyperglycemia, headache, nausea, and injection site reaction. Arrowhead is launching a patient support program called Rely On REDEMPLO to provide services and resources, including financial assistance, and the drug is expected to be available in the U.S. before the end of the year.

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