big news NMPA Accepts Marketing Application for VASCEPA® (icosapent ethyl) Cardiovas
NMPA Accepts Marketing Application for VASCEPA® (icosapent ethyl) Cardiovascular Risk Reduction (CVRR) Indication
SHANGHAI, CHINA, November 14, 2023 - EDDING announced that the new indication marketing application for the innovative cardiovascular drug VASCEPA® (icosapent ethyl) has been officially accepted by the National Medical Products Administration (NMPA).This indication would allow for VASCEPA® to be used in combination with statins for adult patients with elevated and high triglycerides (TG)and established cardiovascular disease or diabetes mellitus with ≥2 other cardiovascular disease risk factors, combined with hypertriglyceridemia, to prevent and reduce the risk of cardiovascular events (including cardiovascular death, myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization).
Over the past three decades, standardized therapy with statins has been widely recognized as the gold standard in the management of cardiovascular events, and it can reduce 25%-35% of cardiovascular event risk. However, there is still residual cardiovascular risk after statin therapy. Hypertriglyceridemia is an important component of residual cardiovascular risk and an urgent clinical issue to be addressed. A large-scale cardiovascular outcome study of VASCEPA® (REDUCE-IT) showed that IPE could significantly reduce the relative risk of primary adverse cardiovascular events by 25% in secondary prevention and primary prevention patients on statin therapy with persistent hypertriglyceridemia.
In December 2019, based on the strong evidence-based results of REDUCE-IT, the U.S. Food and Drug Administration (FDA) approved VASCEPA® for a new cardiovascular risk reduction (CVRR) indication, expanded from its original very high triglycerides (VHTG) indication, making it the first and only FDA-approved prescription triglyceride-lowering drug to reduce cardiovascular events (myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization) in adult statin-treated patients with elevated triglyceride levels (≥150 mg/dL) and other risk factors for cardiovascular disease. At present, VASCEPA® has been approved in the U.S., Canada, the European Union, the United Kingdom, and many other countries/regions for the CVRR indication with more than 20 million prescriptions.
EDDING and AMARIN reached an exclusive licensing agreement in 2015, whereby EDDING has the right to develop and commercialize VASCEPA® in Greater China, including Mainland China, Hong Kong, Macau and Taiwan. VASCEPA® has been approved for the CVRR indication in Hong Kong, China. The official acceptance of its marketing application for the CVRR treatment on the Chinese mainland by the NMPA is expected to benefit many Chinese patients with Atherosclerotic Cardiovascular Disease (ASCVD) from this epoch-making innovative drug.
"We are very pleased that the application for the CVRR Indication of VASCEPA® was accepted by the NMPA”, said Jing Zhai, Vice President of Business Department, EDDING. “Low-density lipoprotein cholesterol (LDL-C) has been the focus of lipid management in clinical practice for many years, but there is a lack of a good and effective therapy to control the residual cardiovascular risk associated with elevated TG levels despite statin therapy. For the currently submitted indication, VASCEPA® can provide a new and strong evidence-based treatment option to reduce residual cardiovascular risk in statin treated patients with elevated and high TG levels in clinical practice. We hope that in the future, VASCEPA® could help to reduce ASCVD risk and events in patients, contributing to the comprehensive management and prevention of cardiovascular diseases in China."
“On behalf of the Amarin we team, we congratulate our partners at EDDING for this critical step in their efforts to secure the CVRR indication for VASCEPA® as a potential expanded indication for patients in China," 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 across China and throughout the world. We look forward to EDDING’s continued progress in introducing VASCEPA® across Mainland China.”
After over 20 years of development, EDDING has the clinical research and development capabilities for innovative drugs, high-end production and manufacturing capabilities, and a robust commercial operation network. It is becoming a leading biopharmaceutical company with the vision of "Global for China". The development strategies of EDDING are strictly in accordance with the Outline of the Healthy China 2030 Plan. It focuses on the core therapeutic areas covering anti-infection, cardiovascular, respiratory, blood, etc., where the patient base is large in China, and the diagnosis and treatment rates need to be improved. EDDING keeps on exploring high-quality drugs to meet the potential medical needs in China.
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA® capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid. VASCEPA® was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. 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. Since launch, VASCEPA® has been prescribed more than 20 million times. VASCEPA® is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA®. VAZKEPA® is being commercialized in multiple European countries, including England, Wales, Sweden and Finlan