Amarin Partner EddingPharm Receives Regulatory Approval for Vascepa® (Icosapent Ethyl
-- VASCEPA Approved by the National Medical Products Administration (NMPA) as an Adjunct to Diet to Reduce Triglyceride Levels in Adult Patients with Severe Hypertriglyceridemia (≥ 500 mg/dL) --
-- EddingPharm Now Working Towards Preparing for Commercial Launch of VASCEPA Across Mainland China Expected by Year-End --
DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).
Following regulatory approval, EDDING is now focusing on National Reimbursement Drug Listing (NRDL) and preparing for commercial launch in China, expected by year-end, as well as on advancing regulatory submission and review for an additional indication in cardiovascular risk reduction (CVRR).
According to a recent report on cardiovascular health and disease in China,i cardiovascular disease (CVD) accounted for 44-47% of all death in urban and rural areas in China, meaning two out of every five deaths were due to CVD. It is estimated that 330 million patients suffer from CVD in China,i and that China has one of the highest CVD death rates in the world.ii According to the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are projected to increase by 50 percent among the population in China between 2010 and 2030 (based on population aging and growth alone).ii
“We congratulate our partner, EDDING, on the regulatory approval of VASCEPA in Mainland China, as this marks an important step in the process of offering this novel treatment to patients across that country,” said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin. “This milestone represents important progress in our vision and efforts to ensure that the unique benefits of VASCEPA are made available to patients throughout the world. We look forward to EDDING’s continued progress in introducing VASCEPA to patients across Mainland China.”
“We are glad to receive this regulatory approval of VASCEPA from the NMPA China, and we are looking forward to securing reimbursement for this important product for patients and to a future CVRR indication approval,” said Rebecca Xu, Vice President of Clinical Development, EDDING. “Prevention and treatment of cardiovascular disease (CVD) is one of the major initiatives promoted by Healthy China 2030. However, few new CVD medications other than statins were launched in the market during the past several decades. In November 2020, EDDING announced the positive, statistically significant top-line results of the Phase 3 clinical trial conducted in Mainland China in severe hypertriglyceridemia patients. We will continue working with Amarin to bring this innovative drug into China to benefit Chinese patients.”