BEDMINSTER, N.J. and DUBLIN, Ireland, April 23, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Food and Drug Administration (FDA) has accepted its Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa (R) (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. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA. "We are very pleased that the FDA has accepted our sNDA submission for the ANCHOR indication, which supports the potential expansion of the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 mg/dL and mixed dyslipidemia. We estimate that one in five, or nearly 40 million, U.S. adults have triglyceride levels ranging from 200 to 499 mg/dL," stated Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The 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. 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."
About Vascepa® (icosapent ethyl) capsulesVascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule. Indications and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
Vascepa has been approved for use by the FDA as an adjunct to diet to lower triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as marketing the use of Vascepa in any indication that has not been approved by the FDA.
CONTACT: Amarin contact information: Joseph Bruno Investor Relations and Corporate Communications Amarin Corporation In U.S.: +1 (908) 719-1315 email@example.com