AstraZeneca announced that the FDA has approved Epanova (omega-3-carboxylic acids) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (>500mg/dL). Epanova is the first prescription omega-3 in free fatty acid form.
Possible mechanisms of action of Epanova include inhibition of acyl-CoA:1,2–diacylglycerol acyltransferase, increased mitochondrial and peroxisomal beta-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Epanova may reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.
The approval was based on data from a clinical program that included positive results from the Phase 3 EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial, which studied the efficacy of Epanova in lowering TG and other key lipid parameters in patients with very high TG levels.
Epanova will be available as 1g strength softgel capsules in 60-count bottles.
For more information call (800) 236-9933 or visit Epanovahcp.com.