Abbott’s Omacor Brings Omega-3s To Rx Drug Market As Adjunct Therapy
This article was originally published in The Tan Sheet
Executive Summary
Abbott Lab's prescription drug Omacor is the first omega-3 fatty acid product to gain FDA approval as a new molecular entity
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Abbott Lab's prescription drug Omacor is the first omega-3 fatty acid product to gain FDA approval as a new molecular entity. Omacor (omega-3-acid ethyl esters) is indicated as an "adjunct to diet to reduce very high (> 500 mg/dL) triglyceride (TG) levels in adult patients," according to FDA's Nov. 10 approval letter. Abbott's Ross Products Division filed the NDA for Omacor on Jan. 20 and received a standard review. Reliant is expected to market Omacor in the U.S. using product manufactured by Cardinal. In foreign markets, the drug is registered for secondary prevention after myocardial infarction and for primary treatment of hypertriglyceridemia. Solvay licenses Omacor from Pronova Biocare in the UK, Germany, Ireland, Greece, Austria, Belgium, Switzerland, the Netherlands and Luxembourg. The approval follows FDA's recent announcement of a qualified health claim for reduced risk of coronary heart disease for conventional foods containing omega-3 fatty acids (1 (Also see "Industry Qualifies Enthusiasm For Omega-3 Qualified Health Claim" - Pink Sheet, 13 Sep, 2004.), p. 12). Ross submitted the results from two clinical studies to substantiate the Omacor approval. The double-blind, randomized, placebo-controlled studies involved 84 adult patients with triglyceride levels between 500 and 2,000 mg/dL who took either placebo or 4 g of Omacor daily. The studies covered six-week and 16-week periods, respectively. Ross says Omacor reduced median TG and non HDL-cholesterol levels, as well as increased median HDL-cholesterol levels compared to placebo. Omacor's mechanism is "not completely understood," Ross states. "Omacor may reduce the synthesis of triglycerides 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 effect of Omacor on cardiovascular mortality and morbidity in patients with very high TG levels has not been determined," Ross states in its NDA. The firm also lists the adverse events experienced by patients in the randomized clinical trials, which included back pain, flu syndrome, infection, skin rash and dyspepsia. |