19 May 2016 - The TGA approved alirocumab (Praluent) on 17 May 2016.

Praluent is indicated for use as an adjunct to diet and exercise in adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease:

• in combination with a statin, or statin with other lipid-lowering therapies or;
• in combination with other lipid-lowering therapies in patients who are statin-intolerant.

The label for Praluent is narrower than that for evolocumab (Repatha) which was approved by the TGA on 9 December 2015 for use by adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

For more details, go to: http://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia