Amarin Corp. (AMRN: Quote) said Thursday the U.S. Food and Drug Administration has approved Vascepa to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (very high triglycerides). Vascepa is to be used as an adjunct to diet to reduce high triglyceride levels.
This is Amarin's first drug that has passed muster with the FDA.
Vascepa will now compete with GlaxoSmithKline Plc's (GSK, GSK.L) Lovaza.
"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,'" said Amarin CEO Joseph Zakrzewski.
Zakrzewski further said, "Amarin continues to anticipate commercial launch of Vascepa early in the first quarter of 2013, and we continue to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support..."
Severe hypertriglyceridemia refers to a condition in which patients have very high levels of triglycerides (greater than or equal to 500 mg/dL) in the bloodstream. Amarin estimates that approximately 4 million people in the United States have severe hypertriglyceridemia.
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by RTT Staff Writer
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