
Arrowhead Pharmaceuticals Secures Health Canada Approval for REDEMPLOâĒ (plozasiran) to Treat Adults with Familial Chylomicronemia Syndrome (FCS)
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Arrowhead Pharmaceuticals, Inc. announced that Health Canada has granted approval for REDEMPLOâĒ (plozasiran) as a treatment to reduce triglyceride levels in adults with Familial Chylomicronemia Syndrome (FCS), a rare genetic disorder marked by extremely high triglycerides and increased risk of acute pancreatitis. The approval authorizes REDEMPLO as an adjunct to diet for patients whose triglyceride levels remain inadequately controlled by standard therapies.
REDEMPLO is a small interfering RNA (siRNA) medicine designed to silence APOC3 RNA, a key protein involved in triglyceride metabolism, and can be self-administered at home via subcutaneous injection once every three months. The regulatory decision was supported by data from the Phase 3 PALISADE clinical trial, which demonstrated significant triglyceride reductions in treated patients compared with placebo.
FCS is considered a severe and rare condition, with triglyceride levels up to 10â100 times above normal, posing serious health risks including potentially fatal pancreatitis. The new approval aims to expand treatment options for the FCS community across Canada.
Arrowhead continues to work on patient support programs and treatment access, and REDEMPLO has received multiple special designations, including Breakthrough Therapy and Orphan Drug status from regulatory authorities.
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