EDDING today announced that VASCEPA® (icosapent ethyl) has been approved for a cardiovascular risk reduction (CRR) indication “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated TG levels (≥150 mg/dL) and established CVD or diabetes mellitus and two or more additional risk factors for CVD.” by the China Hong Kong authority.
EDDING and Amarin Corporation plc entered into an exclusive license agreement in 2015 for the development and commercialization of VASCEPA in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.
VASCEPA is a single-molecule product. It is a highly purified omega-3 fatty acid (EPA) ethyl ester. VASCEPA is the first drug approved by the FDA as an adjunct to maximally tolerated statin therapy for the approved cardiovascular risk reduction (CRR) indication. The REDUCE-IT cardiovascular outcomes trial, which was published in The New England Journal of Medicine in 2018, showed that, VASCEPA can provide a 25% risk reduction in the five-point major adverse cardiovascular event primary composite endpoint on top of standard statin treatment compared to statin therapy plus placebo.
Based on the research data of REDUCE-IT and the approvals of VASCEPA in the United States, Canada and other countries, the application for drug approval of VASCEPA was submitted to the Hong Kong health authority, and approval on February 23rd 2022. The company is evaluating launch opportunities and is planning a potential commercial launch later this year. The new drug application (NDA) for VASCEPA in Mainland China is currently under review by the Chinese National Medical Products Administration (NMPA), and the NDA includes the previously announced successful results of the Phase 3 study conducted by EDDING and all of the Phase 3 studies conducted by Amarin.
“We are very pleased to know that VASCEPA was approved in Hong Kong,China for a CRR indication.” stated Weidong Huang, Chief Operation Officer, EDDING, “VASCEPA has been a recommendation on multiple professional ASCVD guidelines or scientific/consensus statements in the U.S. and Europe including ADA, ESC, etc. It is also recognized by more than 20 treatment guidelines, scientific or consensus statements on cardiovascular diseases and diabetes, including in China. Cardiovascular Disease (CVD) is the heaviest disease burden and the leading cause of death in China and there are still a large number of unmet needs. We believe the launch of VASCEPA in Hong Kong,China will help Chinese patients live a healthier and longer life. EDDING commits to provide patients with high-quality global medical products. This approval of VASCEPA in Hong Kong,China is a new milestone for us.”
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018. Compared to placebo, administration of VASCEPA 4 g/d demonstrated 25% risk reduction in major adverse cardiovascular events (5 MACE composite endpoint). The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. In December 2019, the new cardiovascular risk indication for VASCEPA was approved by the FDA and it was launched as the first drug for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA has approval to be marketed in the USA, Europe (centralized procedure), Great Britain, Canada, Lebanon, the United Arab Emirates, Qatar, Bahrain and Kuwait.