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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Rejects Amarin’s Appeal on Vascepa ANCHOR SPA

Nov. 25, 2013
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The FDA’s Office of New Drugs has notified Amarin that it is refusing to review the company’s appeal of the agency’s decision to rescind the special protocol assessment (SPA) for the drugmaker’s ANCHOR study of its heart drug Vascepa.

The FDA rejected the appeal on procedural grounds, denying the company’s additional request to meet with high-level officials regarding the appeal, Amarin said in an SEC filing Thursday.

Amarin was told it would first need to address the matter at the division level within the agency. Amarin believes its appeal is “procedurally correct” and plans to continue to pursue the appeal and approval of the Vascepa (icosapent ethyl) sNDA, the drugmaker added.

Amarin is seeking a second indication for Vascepa as a treatment for patients with mixed dyslipidemia at high risk for coronary heart disease and currently taking statins. The drug was first approved in 2012 as an adjunct to diet and exercise to lower triglyceride levels in adults with severe hypertriglyceridemia.

The FDA’s decision to rescind the SPA was based on three separate outcome trials of other heart drug candidates, which the agency said “fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events” in the intended patient.

The SPA rescission came days after a panel of agency advisors recommended against approval of Amarin’s sNDA for Vascepa. The advisory vote prompted Amarin to slash staff in order to stay afloat as it tries to win an expanded indication. — Lena Freund

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