Amarin Shares Topline Data from Partner’s Pivotal Phase 3 Study of VASCEPA® (Icosapent Ethyl) in Mainland China
November 19, 2020 at 18:30 PM EST
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 Icosapent Ethyl in Chinese Patients with Very High Triglycerides (>500 mg/dL)
Results Support Upcoming Submission by Partner, Edding, Seeking Regulatory Approval in 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<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.
“We are proud to share news of these positive data from our partner’s pivotal Phase 3 clinical study of VASCEPA in China. Elevated triglycerides are a known marker of risk for pancreatitis and for cardiovascular disease. The statistically significant reduction in TG levels seen with the VASCEPA 4 gram per day dose in the study highlights its potential to address an unmet medical need in China, where hypertriglyceridemia is on the rise,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer at Amarin. “This pivotal study in China mirrored Amarin’s MARINE study in patients from the United States and other countries, and we are pleased that the data show consistency across the Chinese and non-Chinese study populations. With these favorable data, we now look forward to supporting our partner, Edding, in compiling and submitting its dossier at the earliest possible opportunity for regulatory review in China.”
“We are very pleased that the Phase III clinical study of VASCEPA in Mainland China has achieved positive results. Cardiovascular (CV) disease is the largest cause of death in China with significant unmet needs to address. Prevention and treatment of CV diseases is one of the major initiatives promoted by Health China 2030. VASCEPA is anticipated to be launched to further address these pressing needs. We will try our best to promote VASCEPA to market as soon as possible in order to benefit more Chinese patients," said Mr. Xin Ni, founder, chairman and CEO of Edding. "VASCEPA has huge commercial potential in the fast-growing Chinese market. We will work with Amarin to submit the new drug application as soon as possible to bring this cross-era innovative drug to China.”
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.
About Hypertriglyceridemia in China
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
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