Amarin Corp (AMRN) Files sNDA with U.S. FDA for Vascepa; Sees Response in 74 Days

February 26, 2013 6:44 AM EST
Amarin Corporation plc (Nasdaq: AMRN) has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and <500 mg/dL) with mixed dyslipidemia. Amarin expects to hear within 74 days from the FDA whether the sNDA submission has been accepted for review (inclusive of the standard 60-day review and the standard 14-day communication periods).

"This submission marks another significant milestone achieved for Amarin. Data from our pivotal Phase 3 placebo-controlled ANCHOR study showed that Vascepa is unique in that it significantly lowered both triglycerides and LDL-cholesterol on top of optimized statin therapy and exhibited a safety and tolerability profile similar to placebo, unlike the clinical results of other triglyceride-lowering therapies," said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The submission of this sNDA for Vascepa follows the FDA approval and recent launch of Vascepa for use as an adjunct to diet to lower triglyceride levels in adult patients with severe (TG ≥500 mg/dL) hypertriglyceridemia. If approved for the ANCHOR indication, Vascepa will be the only approved prescription omega 3 therapy for cardiovascular health management in this patient population (TG ≥200 mg/dL and <500 mg/dL with mixed dyslipidemia) and will represent the next generation of lipid management for potentially millions of patients."

It is estimated that one in five, or nearly 40 million U.S. adults, have triglyceride levels greater than 200 mg/dL. In the United States alone, it is estimated that 75 million adults have triglyceride levels greater than 150 mg/dL (population studied in the ongoing Vascepa REDUCE-IT cardiovascular outcomes study), including 4 million people with severe hypertriglyceridemia (Vascepa approved indication) and 36 million people with high triglyceride levels (the triglyceride range studied in the ANCHOR trial). Clinical treatment guidelines include recommendations for triglyceride reductions in adults with triglyceride levels greater than 200 mg/dL1 and it is believed that each group represents a potential multi-billion dollar market opportunity. In the top seven world markets it is estimated that the number of people with elevated triglyceride levels is at least two times that of the United States alone.

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