Shots:
- Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factors
- The recommendation is supported by the P-III (VESALIUS-CV) study involving ≥12,000 pts., Repatha reduced the risk of 3-P MACE comprising CHD death, heart attack, or ischemic stroke by 25%. It also lowered the risk of a broader 4-P MACE, which included any ischemia-driven arterial revascularization, by 19% and risk of heart attack by 36% vs PBO when added to optimized lipid-lowering therapy
- Repatha is currently approved in the EU for primary hypercholesterolemia, mixed dyslipidemia, and reducing cardiovascular risk in adults with established ASCVD. The EC is expected to make a final decision on the expanded indication in the coming months
Ref: Amgen | Image: Amgen | Press Release
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