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New 2019 Updates to the European Society of Cardiology's and European Atherosclerosis Society's Guidelines for the Management of Dyslipidaemias Incorporate Findings from the REDUCE-IT™ Cardiovascular Outcomes StudyBEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have updated their Clinical Practice Guidelines for the Management of Dyslipidaemias. This 2019 update incorporates findings from the REDUCE-IT™1,2 cardiovascular outcomes study and includes the recommendation that icosapent ethyl, 2g twice a day, should be considered for patients with cardiovascular disease who have triglyceride levels 135 mg/dL to 499 mg/dL despite statin treatment, which places them at high risk of cardiovascular events, such as heart attack, stroke or death.3 This new recommendation incorporates icosapent ethyl specifically. Icosapent ethyl, studied in a series of clinical trials, including the globally conducted REDUCE-IT study, was developed by Amarin and is exclusively marketed by Amarin and its commercial partners in capsule form under the brand name Vascepa® (icosapent ethyl). In the United States, Vascepa is currently approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (=500 mg/dL) hypertriglyceridemia. Amarin has submitted a supplemental new drug application (sNDA) to the U.S. FDA for an expansion of the Vascepa U.S. FDA label based on the landmark REDUCE-IT results showing reduction of cardiovascular events in high risk patients. The company plans to submit an application seeking approval for icosapent ethyl in Europe for reducing cardiovascular events before the end of 2019. A similar application has already been submitted and is under priority review by Health Canada. ESC and EAS do not provide endorsements or any form of certification for brand name commercial products. Accordingly, the inclusion of icosapent ethyl in the Clinical Practice Guidelines for the Management of Dyslipidaemias should not be understood as an endorsement or approval by ESC or EAS of Vascepa. “We are pleased by ESC and EAS’s acknowledgement of the significance of the REDUCE-IT results as evidenced by their 2019 updates of the Clinical Practice Guidelines for the Management of Dyslipidaemias,” says Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “Amarin believes strongly in the potential for icosapent ethyl to be an important treatment option for the millions of high-risk patients who are on statin therapy with controlled cholesterol levels, yet have elevated triglycerides and other cardiovascular risk factors. This update comes just weeks after the American Heart Association issued an advisory statement referencing REDUCE-IT and the cardiovascular risk-lowering effects of icosapent ethyl and months after the American Diabetes Association included the REDUCE-IT results as part of its updates to the Standards of Medical Care in Diabetes for 2019.4, [5] All of these updates further support the use of icosapent ethyl as an important treatment option for appropriate patients at high risk of cardiovascular events.” Based on the results of REDUCE-IT, the 2019 updates to the Clinical Practice Guidelines for the Management of Dyslipidaemias specifically recommend that: In high-risk (or above) patients with TG [triglycerides] levels between 1.5 – 5.6 mmol/L (135-499 mg/dL) despite statin treatment, n-3 PUFAs [polyunsaturated fatty acids] (icosapent ethyl 2x2 g/day) should be considered with a statin.6 The ESC and EAS recommendation is classified as a IIa recommendation denoting that icosapent ethyl should be considered for treatment of such patients. The classification is a Level B recommendation which reflects a relatively high weight of scientific evidence under ESC and EAS standards. Such recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. In the United States, approximately 15 million people match the criteria of the REDUCE-IT studied population, with triglycerides = 135 mg/dL and other cardiovascular risk factors, despite statin treatment.7 About 25 percent of a representative sample survey of more than 7,800 patients from 27 European countries with coronary heart disease and controlled cholesterol levels had triglyceride levels of 150 mg/dL or greater, illustrating the potential pervasiveness of high-risk cardiovascular disease in Europe.8 “These updated guidelines from such prestigious organizations reaffirm the importance of the REDUCE-IT findings to patients globally, not only in enhancing care, but also in broadening awareness of the need for treatment among patients who may have their cholesterol controlled with a statin, but remain at risk because of elevated triglycerides,” says Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and principal investigator and steering committee chair for REDUCE-IT. “Based on what we’re learning from REDUCE-IT and the related guidance from ESC and EAS, I foresee the beginning of a global change in clinical practice in how best to treat patients with multifactorial risks of cardiovascular events beyond cholesterol management.” Amarin acknowledges the rigor with which the Clinical Practice Guidelines for the Management of Dyslipidaemias are crafted and approved by the ESC’s and EAS’s task force, which is comprised of more than 15 leading professionals in the European Union who specialize in the care of patients with dyslipidaemias. The complete 2019 updates to the Clinical Practice Guidelines for the Management of Dyslipidaemias can be accessed online by clicking here. About Amarin REDUCE-IT™ Study More information on the REDUCE-IT study results can be found at www.amarincorp.com. About Cardiovascular Disease Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.11 Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.12, 13,[14],[15] About Vascepa® (icosapent ethyl) Capsules The FDA has not reviewed and opined on a supplemental new drug application related to REDUCE IT. FDA has thus not reviewed the information herein or determined whether to approve Vascepa for use to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)
Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Important Safety Information for Vascepa based on REDUCE-IT, as previously reported in The New England Journal of Medicine publication of the primary results of the REDUCE-IT study:
Important Cautionary Information About These Data Forward-Looking Statements Availability of Other Information About Amarin Amarin Contact Information Lee M. Stern Media Inquiries: References 1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22. 2 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol 2019;73(22):2791-2802. 3 Mach F, Baigent C, Catapano A L, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology and European Atherosclerosis Society 4 Skulas-Ray AC, Wilson PWF, Harris WS, et al. Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association. 2019. 5 American Diabetes Association. Diabetes Care 2019 Jan; 42(Supplement 1): S103-S123. https://doi.org/10.2337/dc19-S010 6 Mach F, Baigent C, Catapano A L, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology and European Atherosclerosis Society 7 Philip S, Fan W, Granowitz C, Toth P, Wong N. Prevalence of US adults with triglycerides =135 mg/dL: NHANES 2007-2014. J Clin Lipidol. 2019; epub ahead of print. https://els-jbs-prod-cdn.literatumonline.com/pb/assets/raw/Health%20Advance/journals/jacl/jacl_abstracts-1558015686367.pdf 8 De Backer G, Jankowski P, et al. on behalf of the EUROASPIRE V collaborators* Management of dyslipidaemia in patients with coronary heart disease: Results from the ESCEORP EUROASPIRE V survey in 27 countries, Atherosclerosis (2019), doi: https://doi.org/10.1016/ j.atherosclerosis.2019.03.014. 9 American Heart Association. 2018. Disease and Stroke Statistics-2018 Update. 10 American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035. 11 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. 12 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145. 13 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740. 14 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563. 15 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635. |