Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. This focus includes a commitment to providing grants to support research and education in the disease state including the funding of an ongoing outcomes trial.
Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is an ultra-pure, EPA-only omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
In July 2012, Vascepa received FDA approval in the United States for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia and is now available by prescription. The triglyceride lowering effect of Vascepa® is not associated with increases in LDL-C, bad cholesterol. The only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa treated patients was arthralgia (2.3% for Vascepa vs. 1.0% for placebo).
Amarin is also developing Vascepa for use in the treatment of adult patients with high triglyceride levels (≥200 mg/dL and <500 mg/dL) who are also on statin therapy for elevated LDL-C levels, the population studied in the ANCHOR trial. The FDA has not completed its review of the clinical results of the ANCHOR trial. Amarin is also conducting a cardiovascular outcomes study designed to evaluate the efficacy of Vascepa® in reducing cardiovascular events in a high-risk patient population on statin therapy called the REDUCE-IT trial.
Amarin plans to separately seek FDA approval for use of Vascepa in this patient population after Amarin's REDUCE-IT cardiovascular outcomes trial is substantially underway. Each of the MARINE, ANCHOR and REDUCE-IT studies is the subject of a Special Protocol Assessment (SPA) agreement with the FDA.
Amarin is headquartered in Dublin, Ireland. In the U.S., the company's office is in Bedminster, New Jersey. Amarin is listed in the U.S. on NASDAQ (symbol: "AMRN").
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