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FDA Approves Prescription Fish Oil Pill to Treat High Triglycerides–Vascepa

Posted Jul 27 2012 4:30pm

Amarin is the pharmaceutical company that makes the pill.  Patients who have fish or shell fish issues are advised to be careful.  More information below.  BD

From the website:
“Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to imageimprove cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa™ (icosapent ethyl) capsules is Amarin's first FDA approved product. Vascepa is a patented, ultra-pure omega-3 fatty acid, comprising not less than 96% EPA (icosapent ethyl) in a capsule.”

The Food and Drug Administration (FDA) has approved a new prescription fish oil formulation (Vascepa) for the treatment of high levels of triglycerides (TG). The drug is indicated as an adjunct to diet in adult patients with severe hypertriglyceridemia (TG > 500 mg/dL) who are at risk for stroke and heart attack. This is the second prescription fish oil pill to receive FDA clearance. 

Meanwhile, the REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial) trial, which is currently underway, is looking to evaluate the efficacy of Vascepa when given in addition to  a statin in reducing major cardiovascular events in a high-risk population.

http://www.cardiosource.org/Advocacy/Issues/Food-and-Drug-Administration/FDA-Updates/Vascepa.aspx?w_nav=Twitter


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