![]() ![]() Among all HTG patients in China, there were approximately 9 million adults who had very high TG levels (greater-than or equal to500 mg/dL). About Hypertriglyceridemia in China There were approximately 180.4 million hypertriglyceridemia (HTG) patients in China in 2019, representing approximately 20.2% of the adult population. The complete 2021 updates to the Guidelines for Primary Prevention of Cardiovascular Diseases from the CSC can be accessed online here. Amarin acknowledges the rigor with which the Guidelines for Primary Prevention of Cardiovascular Diseases are crafted and approved by the CSC, which is comprised of leading medical professionals in China who specialize in the care of patients with cardiovascular disease. The CSC guideline does not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guideline should not be construed as an endorsement or approval by the CSC of VASCEPA. Accordingly, CSC Guidelines for Primary Prevention of Cardiovascular Diseases reference icosapent ethyl. The CSC does not provide endorsements of any brand name commercial product. CSC cited that its recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. The classification is an Evidence Level B recommendation which reflects that the evidence comes from a single randomized trial or multiple large non-randomized studies. ![]() The CSC recommendation is classified as a Category IIa recommendation denoting that icosapent ethyl is useful and effective and should be considered for treatment of at-risk patients. These findings will provide support as Edding progresses towards and through the next steps of regulatory submission and review of VASCEPA for potential approval in Mainland China. This pivotal study mirrored Amarin's MARINE study in patients from the United States and other countries and showed consistency across the Chinese and non-Chinese study populations. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (greater-than or equal to500 mg/dL), met its primary efficacy endpoint and demonstrated a safety profile similar to placebo. In November 2020, Amarin shared positive, statistically significant top-line results from a Phase 3 clinical trial of VASCEPA conducted in China by Amarin's partner, Edding. Similar to Europe, where the European Society of Cardiology and the European Atherosclerosis Society added icosapent ethyl to their medical treatment guidelines prior to completion of the ongoing regulatory submission and review processes for VASCEPA (icosapent ethyl), CSC inclusion of icosapent ethyl in its updated treatment guidelines has been made separate from and in advance of completion of the analogous regulatory processes for VASCEPA in China. "Importantly, these updated guidelines also support that the preventive effect of omega-3 fatty acids on ASCVD is not only related to the dose, but also to the type and formulation of omega-3 fatty acid and incorporates findings from the REDUCE-IT cardiovascular outcomes study of VASCEPA." "With this new recommendation, icosapent ethyl is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations internationally, solidifying its role as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event," added Dr. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. The guideline authors include "icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population." "Inclusion of icosapent ethyl in the CSC treatment guidelines further validates the increasing independent support and acceptance of this unique drug to reduce cardiovascular risk," stated Craig B. Icosapent Ethyl Included in the Chinese Society of Cardiology (CSC) Updated Guidelines for Primary Prevention of Cardiovascular Diseases 04:30:04 PM ET (GlobeNewswire) Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases.
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