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Leqvio
Published
Product name
Leqvio
Active ingredient
Inclisiran
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Leqvio (inclisiran) was approved for the following therapeutic use:
Leqvio 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
How this medicine works
Inclisiran is a cholesterol-lowering double-stranded small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilises the RNA interference mechanism and directs catalytic breakdown of messenger RNA (mRNA) for proprotein convertase subtilisin/kexin type 9. This increases low density lipoprotein cholesterol (LDL-C) receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Leqvio was considered favourable for the therapeutic use approved.