Amarin (AMRN) Wins FDA Approval of Vascepa
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Amarin Corporation plc (Nasdaq: AMRN) announced the U.S. FDA has approved Vascepa^TM (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides). Amarin submitted the NDA for the use of Vascepa in this indication in September 2011.
The efficacy and safety of Vascepa were assessed in Amarin's MARINE clinical trial, a randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting triglyceride levels, between 500 mg/dL and 2000 mg/dL. At baseline, 25% of patients were on concomitant statin therapy, 28% were diabetics, and 39% of patients 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 triglyceride reduction of 33% (p<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4 grams per day also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C (total cholesterol less "good cholesterol") of 18%, Total Cholesterol (TC) of 16%, Very Low Density Lipoprotein Cholesterol (VLDL-C) of 29%, and apolipoprotein B (Apo B) of 9%.
The most commonly reported adverse reaction (incidence >2% and greater than
placebo) in Vascepa treated patients was arthralgia (joint pain) (2.3% for Vascepa vs. 1.0% for placebo).
The efficacy and safety of Vascepa were assessed in Amarin's MARINE clinical trial, a randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting triglyceride levels, between 500 mg/dL and 2000 mg/dL. At baseline, 25% of patients were on concomitant statin therapy, 28% were diabetics, and 39% of patients 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 triglyceride reduction of 33% (p<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4 grams per day also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C (total cholesterol less "good cholesterol") of 18%, Total Cholesterol (TC) of 16%, Very Low Density Lipoprotein Cholesterol (VLDL-C) of 29%, and apolipoprotein B (Apo B) of 9%.
The most commonly reported adverse reaction (incidence >2% and greater than
placebo) in Vascepa treated patients was arthralgia (joint pain) (2.3% for Vascepa vs. 1.0% for placebo).
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