FDA approves Amrin fish oil product extension adaptation

, the FDA announced approval of the use of Vascepa as an ad-assisted treatment to reduce the risk of cardiovascular disease in adults with triglyceride levels above 150 mg/dl. Patients need to be diagnosed with cardiovascular disease, or have diabetes and have two or more additional risk factors for cardiovascular disease. They should also continue to exercise and maintain a healthy diet.Vascepa is the first FDA-approved complementary therapy to be used as a maximum to-dosage statin to reduce triglyceride levels and increase the risk of cardiovascular disease in patients. Statins are used to treat high cholesterol levels and reduce the risk of cardiovascular events. High levels of triglycerides can lead to hardening of the arteries or thickening of the walls of the arteries, increasing the risk of heart attack or stroke.Vascepa is made up of high-purity Icosapent Ethyl, derived from the natural fish oil ingredient omega-3 fatty acids, and is produced using a fda-regulated manufacturing process that removes impurities and retains active ingredients. Vascepa is a prescription drug that fda identifies as a new chemical entity rather than a dietary supplement like regular fish oil. Vascepa's unique clinical characteristics have enabled it to obtain a number of patents internationally, including the ability to reduce triglyceride levels in patients without increasing ldl-c levels. Previously, it had been approved by fda to reduce triglyceride levels in patients with severe high triglycerides.Vascepa's effectiveness and safety was supported by a study of 8,179 patients over the age of 45 with a history of coronary arteries, cerebrovascular, cervical arteries, and peripheral artery obstruction disorders, or over 50 years of age with diabetes and other cardiovascular risk factors. Patients treated with Vascepa were significantly less likely to have cardiovascular events, such as a stroke or heart attack. "The FDA recognizes that more treatment options are needed to treat cardiovascular disease," said Dr. John Sharrett, acting deputy director of the FDA's Center for Drug Evaluation and Research. "
(Drug Mingkangde)