Amarin (AMRN) to Launch Vascepa in U.S. on Jan. 28th
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Amarin Corporation plc (Nasdaq: AMRN) announced that Vascepa® (icosapent ethyl) capsules, a therapy for patients in the United States to treat severe (≥500 mg/dL) hypertriglyceridemia more commonly known as very high triglycerides, or VHTG, is now available by way of physician prescription, and will be supported with a national commercial launch on January 28, 2013.
Vascepa is a new prescription pure-EPA omega-3 therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Triglycerides, like cholesterol, are a type of fat in the bloodstream. It is estimated that approximately four million adults in the United States have VHTG levels.
Vascepa is the first FDA-approved VHTG therapy to have demonstrated, in published controlled clinical trials, significant reduction in levels of triglycerides without elevation in levels of LDL-C and with a tolerability and safety profile similar to placebo. LDL-C is commonly referred to as "bad cholesterol" and is a primary cardiovascular risk factor. Vascepa also significantly improved many other important lipid parameters including apo B, non-HDL-C, TC and VLDL-C.
"Guidelines for the management of very high triglycerides state that reducing TG levels is the primary focus of therapy in patients with VHTG, due to the fact that severe hypertriglyceridemia contributes to the risk of acute pancreatitis," said Eliot A. Brinton, MD, Director, Atherometabolic Research, Utah Foundation for Biomedical Research, and Vice President, American Board of Clinical Lipidology. "Ideally, therapy that lowers very high triglycerides should not elevate LDL-C – a major risk factor for cardiovascular disease, but other VHTG therapies substantially raise LDL-C."
"Amarin has worked closely with leading clinical experts and regulatory authorities to bring this important new prescription pure-EPA omega-3 therapy to patients with very high triglycerides," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Other approved products for treating very high triglycerides have long been associated with raising LDL-C – commonly called bad cholesterol. Vascepa is the first prescription medicine for VHTG that does not raise LDL-C while significantly reducing very high triglycerides and providing a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo. We expect this to be an important consideration in patient care as we educate physicians and other providers about the product."
Vascepa is a new prescription pure-EPA omega-3 therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Triglycerides, like cholesterol, are a type of fat in the bloodstream. It is estimated that approximately four million adults in the United States have VHTG levels.
Vascepa is the first FDA-approved VHTG therapy to have demonstrated, in published controlled clinical trials, significant reduction in levels of triglycerides without elevation in levels of LDL-C and with a tolerability and safety profile similar to placebo. LDL-C is commonly referred to as "bad cholesterol" and is a primary cardiovascular risk factor. Vascepa also significantly improved many other important lipid parameters including apo B, non-HDL-C, TC and VLDL-C.
"Guidelines for the management of very high triglycerides state that reducing TG levels is the primary focus of therapy in patients with VHTG, due to the fact that severe hypertriglyceridemia contributes to the risk of acute pancreatitis," said Eliot A. Brinton, MD, Director, Atherometabolic Research, Utah Foundation for Biomedical Research, and Vice President, American Board of Clinical Lipidology. "Ideally, therapy that lowers very high triglycerides should not elevate LDL-C – a major risk factor for cardiovascular disease, but other VHTG therapies substantially raise LDL-C."
"Amarin has worked closely with leading clinical experts and regulatory authorities to bring this important new prescription pure-EPA omega-3 therapy to patients with very high triglycerides," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Other approved products for treating very high triglycerides have long been associated with raising LDL-C – commonly called bad cholesterol. Vascepa is the first prescription medicine for VHTG that does not raise LDL-C while significantly reducing very high triglycerides and providing a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo. We expect this to be an important consideration in patient care as we educate physicians and other providers about the product."
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