LEQVIO (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
LEQVIO
Date registered
Evaluation commenced
Decision date
Approval time
236 (255 working days)
Active ingredients
inclisiran
Registration type
NCE/NBE
Indication
LEQVIO (solution for injection) is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin intolerant.