Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)
Shots:
- The CHMP has recommended Arrowhead‘s Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26
- Opinion was supported by 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 1 & all multiplicity-controlled key 2EPs, with reductions in TGs & apoC-III. Redemplo (25mg) showed an 80% median TG reduction vs 17% & demonstrated a lower numerical rate of acute pancreatitis; data was published in The NEJM & Circulation
Ref: Businesswire | Image: Arrowhead | Press Release
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