SHANGHAI, CHINA, 1st June, 2023 - EDDING announced that they have received regulatory approval for VASCEPA® (icosapent ethyl or IPE) 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)(VHTG).
Following regulatory approval, EDDING is next focusing on advancing regulatory submission and review for an additional indication for VASCEPA® in cardiovascular risk reduction (CVRR). This proposed supplemental indication would allow 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, to prevent and reduce the risk of cardiovascular events (including cardiovascular death, myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization).
“It is an important milestone for us to receive the regulatory approval for VASCEPA® from NMPA”, said Rebecca Xu, Vice President of Clinical Development, EDDING. “We are preparing for commercial launch in China, as well as advancing regulatory submission and review for an additional indication in cardiovascular risk reduction (CVRR). 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 over the past several decades. We will continue working on promoting this innovative drug in the Chinese market to meet the significant unmet medical need for the benefit of Chinese patients.”
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 Chinai, 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. “We look forward to EDDING’s continued progress to ensure the unique benefits of VASCEPA® are made available across Mainland China.”
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 a 65%-75% residual risk after statin therapy.iiiA 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 high-risk patients with hypertriglyceridemia who previously received statin therapy.
VASCEPA® has been recommended as a secondary and primary prevention medication for cardiovascular disease by more than 50 domestic and international guidelines/consensus statements, including the "2023 China Lipid Management Guidelines" and the "China Primary Prevention Guidelines for Cardiovascular Disease".
In December 2019, based on the results of REDUCE-IT, the U.S. Food and Drug Administration (FDA) approved VASCEPA® for cardiovascular risk reduction (CVRR) in addition to the previous indication for very high triglycerides (VHTG). This approval by the U.S. FDA made VASCEPA® the first and only drug approved for the treatment of the high-risk patients with persistent cardiovascular risk with statin therapy. In addition to the U.S., VASCEPA® has been approved and marketed in Canada, Lebanon, and the United Arab Emirates. Also, its commercialization is ongoing in many European countries, including England, Wales, Sweden, and Finland.
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. In addition, the U.S.-approved VASCEPA® product is currently available in the Boao Lecheng Pilot Zone of International Medical Tourism in Hainan.
About EDDING
With the mission of helping people for a healthy life, EDDING has always persisted to linking global life science and technology to China. With over 20 years of intensive exploration and research, it has the clinical research and development capabilities of innovative drugs, high-end production and manufacturing capabilities, and a robust commercial operation network, becoming an integrated pharmaceutical company with a full industrial chain and the vision of "Global for China". EDDING has developed the development strategy strictly in accordance with the Outline of the Healthy China 2030 Plan. It focuses on the core therapeutic areas covering anti-infection, cardiovascular system, respiratory system, 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 Finland.
i. The Writing Committee of the Report on Cardiovascular Health and Diseases in China. Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary[J]. Biomedical and Environmental Sciences, 2022, 35(7): 573-603. doi: 10.3967/bes2022.079.
ii. World Heart Federation Fact Sheet: Cardiovascular Disease in China. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://world-heart-federation.org/wp-content/uploads/2017/05/Cardiovascular_diseases_in_China.pdf.
iii. 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.