VASCEPA is also available by prescription in Canada, Lebanon, and the United Arab Emirates. 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 approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Am J Cardiol. Call 1-877-900-3784 to buy Vascepa from CanadaDrugsOnline.com, a certified online pharmacy from Canada with lowest prices on Vascepa (Icosapent Ethyl). It is currently available in both brand and generic versions. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. 2014;384:626–635. Call toll FREE 1(877)745-9217 to talk with our Canadian customer service team in … The US Food and Drug Administration (FDA) granted the approval of it (as Vascepa) in … Accordingly, readers should not place undue reliance on any forward-looking statements or information. This trial is being led by Drs. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. Availability of Other Information About Amarin. 2014;384:626–635. 2016;118:138-145.6 Toth PP, Granowitz C, Hull M, et al. J Am Coll Cardiol. Forward-looking statements In addition, Amarin and its licensee’s ability to effectively commercialize Vascepa will depend in part on the ability to continue to effectively finance businesses, efforts of third parties, ability to gain regulatory approvals, create market demand for Vascepa through education, marketing and sales activities, to achieve market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. There were no significant differences between treatments in the overall rate of treatment emergent adverse events or serious adverse events leading to withdrawal of study drug. VASCEPA remains available by prescription in Canada, Lebanon and the United Arab Emirates. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. The final evaluation of the totality of the efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations: new information 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; consideration of REDUCE-IT results in the context of other clinical studies. Vascepa has been granted priority review status by Health Canada which could accelerate the launch of Vascepa in the Canadian market by up to four-and-a … New Drug Submission (NDS) for Vascepa in Canada Anticipated to Be Filed in April 2019 by HLS Therapeutics, Under Agreement with Amarin. Lancet. The Amarin group of companies is not responsible for material contained on other non-Amarin … For more information about Amarin, visit www.amarincorp.com. Before you buy Vascepa, compare prices at U.S., Canadian, and international online pharmacies. While the NDS includes results from the REDUCE-IT™ cardiovascular outcomes study of Vascepa, review of this regulatory submission in Canada is anticipated to be independent of the review of the supplemental new drug application which Amarin recently filed with the U.S. Food and Drug Administration regarding Vascepa based on the same clinical study results. Disease and Stroke Statistics-2018 Update.3 American Heart Association. 2018;72(3):330-343.4 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. The information that Amarin posts on these channels and websites could be deemed to be material information. Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa. Irish heart drug company Amarin’s Vascepa is approved for widespread use in the US, Canada, the United Arab Emirates and Lebanon. VASCEPA IS NOT APPROVED IN CANADA. As previously announced, Vascepa has been granted priority review status by Health Canada. This is the first submission of Vascepa to Health Canada for any indication and, if approved, Vascepa will be the first drug approved in Canada for this important indication. In addition this medication has shown anti-inflammatory properties which may benefit patients affected by COVID-19. Amarin, the developer from which HLS licensed Vascepa 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. 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). Vascepa (icosapent ethyl) is used to reduce cardiovascular risk and treat high triglyceride levels.It is more popular than other comparable drugs. 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. So, there is no generic version available in the United States. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. 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). 5- 8, About Vascepa® (icosapent ethyl) Capsules. Priority review could accelerate the launch of Vascepa in the Canadian market by up to four-and-a-half months if the product is ultimately approved by Health Canada. 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. Circ Res. When typing in this field, a list of search results will appear and be automatically updated as you type. There was no serious adverse event (SAE) occurring at a frequency of >2% which occurred at a numerically higher rate in the statin plus Vascepa treatment group than in the statin plus placebo treatment group.
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