Arrowhead Pharmaceuticals Receives the Health Canada Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots:

• Health Canada has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS who had an inadequate response to standard triglyceride lowering therapies
• Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a 2-part extension period where all receive Redemplo after completing randomization  
• Trial met its 1EP & all multiplicity-controlled key 2EPs, with reductions in TGs & APOC3. Redemplo (25mg) showed an -80% median TG reduction vs -17% in the pooled PBO group & demonstrated a lower numerical rate of acute pancreatitis; data was published in The NEJM & Circulation, & presented at ESC’24 & AHA’24

Ref: PRnewswire  |  Image: Arrowhead  | Press Release

Related News: Arrowhead Pharmaceuticals Receives the US FDA’s Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

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