Significant Reduction in Triglyceride Levels Without Low-Density Lipoprotein Cholesterol (LDL-C) Increase Compared to Placebo and Safety Profile Similar to Placebo Achieved with 4 Grams Per Day Dose of IcosapentEthyl in Chinese Patients with Very High Triglycerides (>500 mg/dL)
Results Support Upcoming Submission by Partner, Edding, Seeking Regulatory Approval in China
#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<0.001) compared to placebo at the end of the 12-week treatment period.
Consistent with Amarin’s MARINE study in a similar patient population, the 4 gram per day dose of VASCEPA in the EDPC003R01 trial did not result in a significant median increase from baseline in low-density lipoprotein cholesterol (LDL-C) compared to placebo at the end of the 12-week treatment period. The primary results of MARINE were published in the American Journal of Cardiology1 in June 2011. Results from the MARINE study were the basis for VASCEPA’s initial approval in the United States for triglyceride lowering before the successful results of the REDUCE-IT® cardiovascular outcomes study.
Importantly, the VASCEPA 4 gram per day dose in EDPC003R01 appeared to be well-tolerated with a safety profile similar to placebo. There were no treatment-related serious adverse events in the EDPC003R01 study.
Amarin intends to support Edding in its pursuit of an appropriate label for VASCEPA in China reflecting the results of EDPC003R01 and all other available data supporting the safety and efficacy of VASCEPA" (see press release HERE).
See our AMRN #Vascepa AmpCard HERE.