Arrowhead Pharmaceuticals received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of its RNAi therapy REDEMPLO (plozasiran) for the treatment of familial chylomicronemia syndrome (FCS).
The CHMP recommendation follows data from the Phase 3 PALISADE study, which showed an 80% median reduction in triglycerides and a significant decrease in acute pancreatitis events compared with placebo. If the European Commission grants marketing authorization in the second quarter of 2026, REDEMPLO would become the first and only siRNA medicine approved in the EU for both genetically confirmed and clinically diagnosed adult patients with FCS.
This regulatory milestone expands Arrowhead’s commercial footprint into the European market, potentially unlocking a new revenue stream for its first approved product and reinforcing the value of its TRiM delivery platform.
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