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REPATHA Amgen Australia Pty Ltd

Product name
REPATHA
Accepted date
Mar-2026
Active ingredients
evolocumab
Summary of proposed indication
REPATHA (evolocumab) is proposed to reduce the risk of death from heart and blood vessel diseases such as heart attack and stroke, to reduce the risk of hospitalisation to manage chest pain due to heart artery narrowing, or procedures to restore blood flow to arteries other than heart arteries. REPATHA is already approved to reduce the risk of heart attack, stroke, and the need for procedures to restore blood flow to heart arteries.
REPATHA is already approved for adults with a diagnosed heart or blood vessel condition. It is proposed to also reduce the risk for adults who have a high chance of having a heart or blood vessel condition such as a heart attack or stroke.
REPATHA is intended taken together with optimally dosed statin and/or other lipid lowering therapies
Application type
C (new indication)
Publication date
Mar-2026