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