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Name | Symbol | Market | Type |
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Amarin Corp PLC | NASDAQ:AMRN | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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0.00 | 0.00% | 0.8393 | 0.84 | 0.8469 | 0 | 01:00:00 |
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 AmarinAmarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.
REDUCE-IT™ StudyREDUCE-IT, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of prescription pure EPA therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated triglyceride levels (at least 135 mg/dL). A large portion of the male and female patients enrolled in this outcomes study were diagnosed with type 2 diabetes.
More information on the REDUCE-IT study results can be found at www.amarincorp.com.
About Cardiovascular DiseaseWorldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths – one death approximately every 38 seconds – with annual treatment cost in excess of $500 billion.9,[10]
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) CapsulesVascepa (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient from degradation. Vascepa, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
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 Further REDUCE-IT data assessment and data release could yield additional useful information to inform greater understanding of the trial outcome. For example, detailed data assessment by regulatory authorities, such as the FDA and Health Canada, will continue and take several months to complete and announce. The FDA advisory committee process and the final evaluation by regulatory authorities of the totality of efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations: new information or analyses affecting the degree of treatment benefit on studied endpoints; study conduct and data robustness, quality, integrity and consistency; additional safety data considerations and risk/benefit considerations; and consideration of REDUCE-IT results in the context of other clinical studies. Because regulatory reviews are typically fluid and not definitive interactions between sponsor and agency on individual elements of an application and related information, Amarin does not plan to update investors on ongoing communications with regulatory authorities. Amarin plans to announce the final outcome of such regulatory reviews when appropriate.
Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the use of Vascepa to potentially help millions of patients. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; the risk that data interpretations or other information from third parties, the regulatory review process, regulatory authorities and in connection with an advisory committee could be made public that are negative or may delay approval or limit Vascepa’s marketability; the risk that special protocol assessment (SPA) agreements with the FDA are not a guarantee that FDA will approve a product candidate; the risk associated with the FDA's rescinding the REDUCE-IT SPA agreement; the risk related to FDA advisory committee meetings; and the risk that the FDA may not complete its review of the REDUCE-IT sNDA within the timing expected. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact InformationInvestor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992 lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735 pr@amarincorp.com
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.
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