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Vascepa (Icosapent Ethyl) Launched in U.S. for Treatment of Hypertriglyceridemia
Omega-3 drug approved as adjunct to diet (Jan. 24)
According to a recent announcement, Vascepa capsules (icosapent ethyl, Amarin Corporation) will receive a national commercial launch on January 28, 2013, for the treatment of severe (= 500 mg/dL) hypertriglyceridemia — commonly known as very high triglycerides (VHTG).
Vascepa — an omega-3 drug formerly known as AMR101 — was approved by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Triglycerides, like cholesterol, are a type of fat in the bloodstream. It is estimated that approximately four million adults in the U.S. have VHTG levels. The drug significantly reduced levels of triglycerides without elevating low-density lipoprotein cholesterol (LDL-C) levels in controlled clinical trials, with a tolerability and safety profile similar to that of placebo. LDL-C is commonly referred to as “bad cholesterol” and is a primary cardiovascular risk factor.
The effect of icosapent ethyl on the risk for pancreatitis or on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
It has been estimated that approximately 4 million people in the U.S. have VHTG. Guidelines for the management of VHTG state that reducing triglyceride levels is the primary lipid treatment goal to reduce the risk of acute pancreatitis.
Source: Amarin Corporation; January 24, 2013.