REDEMPLO (Arrowhead Australia Pty Ltd)
Product name
REDEMPLO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
plozasiran sodium
Registration type
NCE/NBE
Indication
REDEMPLO is indicated as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.