Arrowhead Acquires FDA Priority Review Voucher for Plozasiran sNDA
Arrowhead Pharmaceuticals acquired an FDA priority review voucher to accelerate FDA action on a planned Supplemental New Drug Application for plozasiran. The voucher will support an expanded indication for severe hypertriglyceridemia, with an sNDA submission expected before end-2026. Priority review targets a six-month FDA decision versus 10 months standard, potentially speeding access to REDEMPLO, approved as an adjunct to diet to reduce triglycerides in familial chylomicronemia syndrome by silencing APOC3.