Fish Oils get Fancy! FDA approves Vascepa for heart care
July 30, 2012 § Leave a comment
U.S. Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl), a new prescription-based formulation of fish oils to treat very high levels of triglycerides, or very high levels of fats in the blood stream.
Vascepa, in a 1 gram oral capsule, is indicated as a treatment method as supplement to diet to help reduce triglyceride levels in adults with severe hypertriglyceridemia. Along with cholesterol, triglycerides is a blood fat that contributes to cardiovascular disease. Vascepa contains omega-3 fatty acids, which are contained in fish oil and thought to have heart-protecting properties.
Vascepa, formerly called AMR101, is manufactured by Amarin Corporation plc, a biopharmaceutical company headquartered in Bedminster, New Jersey that focuses on developing therapeutics to improve heart health. Vascepa is Amarin Corporation’s first FDA-approved medication.
“FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia. In Amarin’s MARINE clinical trial, Vascepa demonstrated a statistically significant placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, commonly referred to as ‘bad cholesterol,’” stated Joseph Zakrzewski, Chairman and CEO of Amarin.
Approximately 4 million Unites States adults have severe hypertriglyceridemia ( > 500 mg/dL), according to Amarin.
With Vascepa’s FDA approval, it becomes a competitor for high-selling heart pill Lovaza, manufactured by GlaxoSmithKline Plc.
Amarin hopes to commercially launch Vascepa within the first three months of 2013.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved