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Significant Reduction in TriglycerideLevelsWithoutLow-Density Lipoprotein Cholesterol(LDL-C)Increase Compared to Placeboand Safety Profile Similar to PlaceboAchieved with 4 Grams Per Day Dose of IcosapentEthylin Chinese Patients with Very High Triglycerides(>500 mg/dL)
Results Support Upcoming Submission by Partner,Edding, SeekingRegulatoryApprovalin China
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today shared positive, statistically significant top-line results from Protocol Number EDPC003R01, a Phase 3 clinical trial of VASCEPA® (icosapent ethyl) conducted in China by Amarin partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo. The findings are being prepared to support Edding’s dossier for seeking regulatory approval of VASCEPA in Mainland China.
The EDPC003R01 trial was a multi-center, randomized, double-blind, placebo-controlled, 12-week pivotal study in adult patients in China with qualifying fasting triglyceride (TG) levels greater than or equal to 500 mg/dL and less than or equal to 2000 mg/dL. The median baseline TG levels in the study were 812 mg/dL and 837 mg/dL for the patients assigned to placebo (n=123) and 4 grams per day of VASCEPA (n=122), respectively. Prior to randomization into the 12-week double-blind treatment period, all patients underwent a six- to eight-week washout period of lipid altering drugs, as well as diet and lifestyle stabilization.
The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day VASCEPA dose group. The patient group assigned to 4 grams per day of VASCEPA showed a statistically significant median TG decrease of 19.9% (p
