“This analysis extends the findings to date of the potential lipid and lipoprotein modifying benefits Vascepa possesses in patients with elevated triglyceride (TG) levels,” said Dr. Ballantyne. “It also extends our understanding of the effects Vascepa® has on top of statin therapy.”
The analysis evaluated the effects of EPA-only prescription Vascepa, alone or in combination with statin therapy, on ApoC-III levels in 148 patients with VHTG levels in the MARINE study of Vascepa and 612 patients with HTG levels in the ANCHOR study of Vascepa. In MARINE, Vascepa 4 g/day statistically significantly reduced ApoC-III levels by 25.1% (P < 0.0001) versus placebo. In ANCHOR, Vascepa 4 g/day statistically significantly reduced ApoC-III levels by 19.2% (P < 0.0001) versus placebo. The findings, originally presented at the National Lipid Association Annual Scientific Sessions in 2014, show that at both 4g/day and 2g/day compared to placebo, Vascepa, alone or in combination with statin therapy, significantly reduced ApoC-III levels in adult patients in the MARINE and ANCHOR studies, in which Vascepa also significantly lowered TG levels without raising LDL-C.
Further study is needed to determine if the effects of Vascepa, including those on ApoC-III, in patients with hypertriglyceridemia would have clinically meaningful benefit in the human body.
About VASCEPA® (icosapent ethyl) capsules
VASCEPA® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
- VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for VASCEPA
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promotion the use of Vascepa in any indication that has not been approved by the FDA.
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin’s clinical program includes commitment to an ongoing outcomes study. Vascepa® (icosapent ethyl), Amarin’s first FDA approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visitwww.amarincorp.com.
This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of EPA, including statements about the potential clinical importance of the findings presented. 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 uncertainties associated generally with in vitro research, research and development and clinical trials, including the risk that such study results may not be predictive of future results or replicated in study in man and that studied parameters may not have clinically meaningful effect. A 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 Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), 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 we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.