EDDING ANNOUNCES NMPA APPROVAL OF VASCEPA® (Icosapent Ethyl) FOR NEW CARDIOVASCULAR RISK REDUCTION(CVRR)INDICATION IN MAINLAND CHINA
2024-07-05

SHANGHAI, CHINA, June 28,2024 - EDDING announced that they have received regulatory approval for a new cardiovascular risk reduction (CVRR) indication of VASCEPA® (icosapent ethyl or IPE) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA® to be used in combination with statins for adult patients with established cardiovascular disease or diabetes mellitus with ≥ 2 other cardiovascular disease risk factors, combined with hypertriglyceridemia (≥150 mg/dL), to reduce the risk of cardiovascular events (including myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization).


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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 cardiovascular event risk by 25%-35%. However, there is still a 65%-75% residual risk after statin therapy 1.


A large-scale cardiovascular outcome study of VASCEPA® (REDUCE-IT) showed that VASCEPA® (icosapent ethyl) could significantly reduce the relative risk of primary adverse cardiovascular events by 25% in high-risk patients with hypertriglyceridemia who previously received statin therapy. The relative risks of myocardial infarction, stroke, and cardiovascular death could be reduced by 31%, 28%, and 20%, respectively.


In December 2019, based on the strong evidence-based results of REDUCE-IT, the U.S. Food and Drug Administration (FDA) approved VASCEPA® for cardiovascular risk reduction (CVRR) , 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 United Kingdom, multiple EU countries, and countries in the Middle East for the CVRR indication. IPE has been recommended as a secondary and primary prevention medication for cardiovascular disease by more than 80 domestic and international guidelines/consensus statements, including 2023 ESC Guidelines for the management of acute coronary syndromes, 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, 2019 ESC/EAS Guidelines for the management of dyslipidemias: lipid modification to reduce cardiovascular risk, Chinese Guidelines for Lipid Management (2023), Chinese guidelines for the diagnosis and management of patients with chronic coronary syndrome (2024), Chinese Guideline for Lipid Management (Primary Care Version 2024).


“NMPA approved VASCEPA® for a new cardiovascular risk reduction (CVRR) indication, expanded from its original very high triglycerides (VHTG) indication approved in 2023, reflecting our research and development strength and efficiency with great support from our important partner Amarin. The approval for the CVRR indication in mainland China is expected to benefit many Chinese patients with Atherosclerotic Cardiovascular Disease (ASCVD) from this epoch-making innovative drug.” EDDING says, " We started our business as a contract sales organization. Our long-term experience on the front line of the market enable us to fully understand the real pain points of clinical practice in China, and to quickly identify and develop those products which can meet unmet medical needs as well as have huge market prospects. VASCEPA® is a typical example like this. With the efficient and high-quality clinical development and management capabilities, quickly achieve product launch. Over years of development, we have had the core competitiveness in R&D, manufacture, supply chain, sales, and other areas, EDDING has grown into a leading biopharmaceutical company. In the future, we will keep going forward step by step, and exploring high-quality drugs to meet the potential medical needs in China for the benefit of Chinese patients.


We congratulate our partner, EDDING, on the regulatory approval of VASCEPA® for cardiovascular risk reduction in Mainland China, as this marks an important step in helping broaden access to this novel treatment for patients across that country,” said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin. “This milestone is a major step 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 at-risk for a cardiovascular event across Mainland China.”



About EDDING:

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, hematology, 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 Amarin:

Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.


About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules

VASCEPA  (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on 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 twenty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China and some countries in MENA. 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. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in the United Kingdom VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands.



1.Ganda OP, Bhatt DL, Mason RP, et al. Unmet Need for Adjunctive Dyslipidemia Therapy in Hypertriglyceridemia Management. J Am Coll Cardiol. 2018;72(3):330-343.




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