Repatha (evolocumab; Amgen/Astellas) is a fully human monoclonal immunoglobulin G2 antibody that inhibits PCSK9. PCSK9 is a protease involved in the intracellular and extracellular regulation of low-density lipoprotein receptor (LDLR) expression. It binds to the LDLR and targets it for lysosomal degradation within the hepatocytes. PCSK9 is also known to increase the production of apolipoprotein B-containing lipoproteins. Repatha prevents circulating PCSK9 from binding to the epidermal growth factor-like repeat A domain, its target on the LDLR. This consequently inhibits LDLR degradation, allowing the LDLRs to be recycled to the cell surface, thereby increasing plasma clearance of LDL-C.
LIST OF FIGURES
8 Figure 1: LDL-C lowering in pivotal trials of PCSK9 inhibitors Repatha and Praluent
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Repatha for dyslipidemia
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Repatha for dyslipidemia
17 Figure 4: Repatha sales for dyslipidemia across the US, Japan, and five major EU markets, by country, 2018–27
LIST OF TABLES 5 Table 1: Recent high-impact events for Repatha in dyslipidemia
6 Table 2: Repatha drug profile
7 Table 3: Approval history of Repatha for dyslipidemia in the US, Japan, and five major EU markets
8 Table 4: PCSK9 inhibitors, Repatha and Praluent, cardiovascular outcomes (hazard ratios vs placebo)
10 Table 5: Clinical trials for Repatha in dyslipidemia
12 Table 6: Repatha for dyslipidemia – SWOT analysis
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