Drug Overview Vascepa (icosapent ethyl) is marketed by Amarin for the treatment of severe hypertriglyceridemia. The molecule itself is a semi-synthetic, highly purified derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA). A single mechanism of action explaining the antidyslipidemic effects of Vascepa has not been identified. Studies suggest that Vascepa reduces hepatic very low-density lipoprotein (VLDL) triglyceride (TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. These effects are potentially mediated by increased fatty acid degradation by beta-oxidation, inhibition of acyl-coenzyme oxidase 1/2-diacylglycerol acyltransferase, decreased hepatic lipogenesis, and increased hydrolytic activity of plasma. Despite slow initial sales, Amarin’s marketing partnership with Kowa Company has increased Vascepa’s prescription rates and revenue growth in its current approved indication for severe hypertriglyceridemia. Following the US Food and Drug Administration’s rejection of Vascepa’s supplemental New Drug Application, it seems that further outcomes trials will be required for the drug’s approval in the wider dyslipidemia population. Vascepa is currently enrolled in REDUCE-IT, a large-scale cardiovascular outcomes trial, which passed its first pre-specified interim efficacy analysis in September 2016. Outcomes data will also be vital for Vascepa to distinguish itself from generic forms of its competitor, Lovaza (omega-3-acid ethyl esters; GlaxoSmithKline/AbbVie/Takeda).
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