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-First and Only FDA Approved Pure-EPA Omega-3 Prescription Therapy Now Available-
-Vascepa Reduces VHTG Without Raising LDL Cholesterol-
BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 24, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced that Vascepa® (icosapent ethyl) capsules, a therapy for patients in the United States to treat severe (≥500 mg/dL) hypertriglyceridemia more commonly known as very high triglycerides, or VHTG, is now available by way of physician prescription, and will be supported with a national commercial launch on January 28, 2013.
Vascepa is a new prescription pure-EPA omega-3 therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Triglycerides, like cholesterol, are a type of fat in the bloodstream. It is estimated that approximately four million adults in the United States have VHTG levels.
Vascepa is the first FDA-approved VHTG therapy to have demonstrated, in published controlled clinical trials, significant reduction in levels of triglycerides without elevation in levels of LDL-C and with a tolerability and safety profile similar to placebo. LDL-C is commonly referred to as "bad cholesterol" and is a primary cardiovascular risk factor. Vascepa also significantly improved many other important lipid parameters including apo B, non-HDL-C, TC and VLDL-C.
"Guidelines for the management of very high triglycerides state that reducing TG levels is the primary focus of therapy in patients with VHTG, due to the fact that severe hypertriglyceridemia contributes to the risk of acute pancreatitis," said Eliot A. Brinton, MD, Director, Atherometabolic Research, Utah Foundation for Biomedical Research, and Vice President, American Board of Clinical Lipidology. "Ideally, therapy that lowers very high triglycerides should not elevate LDL-C – a major risk factor for cardiovascular disease, but other VHTG therapies substantially raise LDL-C."