Meeting Materials NOW Available! – Vascepa (icosapent ethyl)

Posted by on October 15, 2013

October 16, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 

The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.

Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.

Please click HERE to view this meeting’s original announcement.

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