- Amgen Inc presented new data from the Phase 3 FOURIER open-label extension (OLE) studies of Repatha (evolocumab) in adults with atherosclerotic cardiovascular disease (ASCVD) for a median follow-up of up to five years and a maximum exposure to Repatha of more than eight years.
- No new long-term safety findings were observed.
- Repatha delivered medically significant and sustained reduction in low-density lipoprotein cholesterol (LDL-C) levels, with 80% of patients achieving low-density lipoprotein cholesterol (LDL-C) levels of <55mg/dL.
- Additionally, the LDL-C reduction of 58% from baseline was consistent over long-term follow-up (week 260) on Repatha.
- An additional prespecified exploratory analysis in the OLE studies showed a lower rate of major adverse cardiovascular events, including cardiovascular death, 20% relative risk reduction for major cardiovascular events, and 23% for cardiovascular death) versus the placebo.
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