Lovaza (omega-3-acid ethyl esters; GlaxoSmithKline/AbbVie/Takeda) was the first omega-3 fatty acid formulation to receive approval from the US Food and Drug Administration for the treatment of severe hypertriglyceridemia. The main components of the drug are ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both derived from fish oil. Lovaza’s mechanism of action is not fully understood, but proposed interactions shed some light on its antidyslipidemic effects. These include: inhibition of acyl-coenzyme oxidase 1/2-diacylglycerol acyltransferase; increased mitochondrial and peroxisomal beta-oxidation in the liver; decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity. It may also reduce the synthesis of triglycerides in the liver, as EPA and DHA are poor substrates for the enzymes involved and they inhibit esterification of other fatty acids.
Lovaza’s US sales have rapidly declined due to generic competition following its patent expiry in 2013. This decline is set to continue as more generics enter the market and the price of Lovaza is subsequently lowered. Lovaza will face further competition from its rival Vascepa (icosapent ethyl; Amarin/Kowa Company), which may provide novel therapeutic advantages. Lovaza’s future use is also threatened in other geographical markets, as uptake is set to remain poor in Japan and recent generic entry in the EU will cause a decline in sales in the five major EU markets (France, Germany, Italy, Spain, and the UK).
LIST OF FIGURES
8 Figure 1: Lovaza for dyslipidemia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Lovaza for dyslipidemia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Lovaza for dyslipidemia
LIST OF TABLES
6 Table 1: Lovaza drug profile
7 Table 2: Lovaza pivotal trial data in dyslipidemia
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