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FDA accepts Amarin omega-3 drug for review

Daily News | November 28, 2011

Kevin Grogan

FDA accepts Amarin omega-3 drug for review

Amarin Corp has been boosted by the news that its investigational fish oil-derived heart drug has been accepted for filing by US regulators.

The Irish-American company, which is listed on the Nasdaq, says the US Food and Drug Administration has decided that the New Drug Application for AMR101 (icosapent ethyl) is "sufficiently complete to permit a substantive review". Amarin hopes that the drug, a prescription-grade omega-3 fatty acid, will be approved for the treatment of patients with very high triglyceride levels.

The NDA is supported by data from two Phase III trials, MARINE and ANCHOR, in which AMR101 achieved all of the primary endpoints and was well tolerated with a safety profile comparable to placebo. The application will have a Prescription Drug User Fee Act date of July 26 next year and Amarin chief executive Joseph Zakrzewski called the acceptance of the filing “a significant achievement in the development of what we believe is a next generation omega-3 based triglyceride-lowering therapy.”

Amarin also plans to separately seek approval for the population studied in the ANCHOR trial ie patients with less elevated triglyceride levels of fat. If approved, AMR101 would compete with GlaxoSmithKline/Pronova Biopharma's Lovaza (omega-3-acid ethyl esters).

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