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. Vascepa® (icosapent ethyl) capsules is Amarin's first FDA approved product and is available in the United States by prescription. Vascepa is the first and only pure EPA omega-3 fatty acid that has been clinically proven to significantly reduce TG levels without increasing LDL-C and providing a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo. For more information about Vascepa visit www.vascepa.com.
Vascepa® (icosapent ethyl) capsules is a patented, pure EPA omega-3 fatty acid clinically proven to reduce triglycerides without raising LDL-C. 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 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 reviewed the clinical results of the ANCHOR 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 U.S. office is in Bedminster, New Jersey. Amarin is listed in the U.S. on NASDAQ (symbol: "AMRN").
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19 Jun 2013
Amarin Informed by FDA of October 16th Advisory Committee Date in Connection With Supplemental New Drug Application (sNDA) for Vascepa(R) in the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia
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