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FDA Approves Icosapent Ethyl for Triglyceride Reduction in Adults
Amarin submitted the New Drug Application (NDA) for the use of Vascepa in this indication in September 2011.
The efficacy and safety of Vascepa were assessed in the MARINE trial, a randomized, placebo-controlled, double-blind, parallel-group study of adults with very high fasting TG levels, (between 500 and 2,000 mg/dL). At baseline, 25% of patients were on concomitant statin therapy; 28% were diabetics; and 39% had TG levels greater than 750 mg/dL.
Patients treated for 12 weeks with the 4-gram dose of Vascepa demonstrated a statistically significant placebo-adjusted median TG reduction of 33% (P
The most commonly reported adverse reaction in Vascepa-treated patients was arthralgia (2.3% for Vascepa vs. 1.0% for placebo).
Vascepa, known in the scientific literature as AMR101, is a patented, ultra-pure omega-3 fatty acid product, comprising not less than 96% eicosapentaenoic acid (EPA) in a 1-gram capsule.
Severe hypertriglyceridemia refers to a condition in which patients have very high levels of TGs (greater than or equal to 500 mg/dL) in the bloodstream. Amarin estimates that approximately 4 million people in the U.S. have severe hypertriglyceridemia. According to The American Heart Association Scientific Statement on Triglycerides and Cardiovascular Disease (2011), triglycerides provide important information as a marker associated with the risk for heart disease and stroke, especially when an individual also has low levels of HDL-C (often referred to as "good" cholesterol) and elevated levels of LDL-C (often referred to as "bad" cholesterol). The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
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