Omega-3 carboxylic acids[1] (Epanova) is a formerly marketed yet still not an Food And Drug Administration (FDA) approved prescription medication–since taken off market by the manufacturer–used alongside a low fat and low cholesterol diet that lowers high triglyceride (fat) levels in adults with very high levels.[2] This was the third class of fish oil-based drug, after omega-3 acid ethyl esters (Lovaza and Omtryg) and ethyl eicosapentaenoic acid (Vascepa), to be approved for use as a drug.[3] The first approval by US Food and Drug Administration was granted 05 May 2014.[4] These fish oil drugs are similar to fish oil dietary supplements, but the ingredients are better controlled and have been tested in clinical trials. Specifically, Epanova contained at least 850 mg omega-3-acid ethyl esters per 1 g capsule.[4]
Following phase III clinical trial in mixed dyslipidaemia, AstraZeneca announced on 13 January 2019 that their clinical trials were terminated for futility because no medical benefit of the medication could be found.[5]
- ^ "Omega-3 carboxylic acids" is the USAN, see here under 2014 and the proposed INN - see 3.8 here
- ^ Cite error: The named reference
emedwas invoked but never defined (see the help page). - ^ Skulas-Ray, Ann C.; Wilson, Peter W.F.; Harris, William S.; Brinton, Eliot A.; Kris-Etherton, Penny M.; Richter, Chesney K.; Jacobson, Terry A.; Engler, Mary B.; et al. (2019). "Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association". Circulation. 140 (12): e673–e691. doi:10.1161/CIR.0000000000000709. PMID 31422671.
- ^ a b Food and Drug Administration, Center for Drug Evaluation and Research (2021). Approved Drug Products with Therapeutic Equivalence Evaluations (41st ed.). Food and Drug Administration. p. 830.
- ^ "AstraZeneca to discontinue Epanova trial, expects $100 million writedown". Reuters. 13 January 2020. Retrieved 15 January 2020.
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