Waylivra (volanesorsen; Ionis Pharmaceuticals) is an antisense drug that inhibits the translation and production of ApoC-III. ApoC-III is a small protein that resides on the surface of very low-density lipoproteins (VLDLs) and high-density lipoproteins (HDLs) in the plasma. ApoC-III plays a central role in the regulation of plasma triglyceride (TG) levels. It is a potent inhibitor of lipoprotein lipase, which catalyzes the breakdown of TG-rich lipoproteins. ApoC-III also inhibits the uptake of these lipoprotein remnants by the liver. Therefore, the net effect of ApoC-III’s activity is the reduced clearance of TGs from the plasma, and the reduced clearance of atherogenic lipoproteins by the liver. ApoC-III also plays a role in vascular inflammation, enhancing endothelial dysfunction by promoting monocyte adhesion. By inhibiting ApoC-III, Waylivra reduces circulating levels of TGs, VLDLs, and ApoC-III, and increases HDL cholesterol (HDL-C) levels, resulting in a potentially less atherogenic lipid profile in patients who receive the drug. It may also protect against the pro-inflammatory effects of ApoC-III, thereby reducing the risk of CV disease.
LIST OF FIGURES
10 Figure 1: Datamonitor Healthcare’s drug assessment summary of Waylivra for dyslipidemia
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Waylivra for dyslipidemia
13 Figure 3: Waylivra 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 Waylivra in dyslipidemia
6 Table 2: Waylivra drug profile
7 Table 3: Approval history of Waylivra for FCS in the US, Japan, and five major EU markets
7 Table 4: Changes in fasting lipid parameters, APPROACH study
8 Table 5: Clinical trials for Waylivra in dyslipidemia
9 Table 6: Waylivra for FCS – SWOT analysis
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