TGA approves Leqvio

TGA

22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid.

The TGA has approved inclisiran (Leqvio) for use 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

Read TGA Prescription Medicine Decision Summary

Michael Wonder

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Michael Wonder

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Medicine , Regulation , Australia