Amarin Corp Plc (AMRN)

[HDGabor]

From BD.

Maybe, but their label at approval (12/15/2008) and now (09/05/2012) is the same. The bold 2 was included from 09/30/2011 and underline was deleted by 09/05/2012. So "funny" to read this label ... Studies 'with Trilipix' enough to deny Vascepa indication, but not enough to withdraw Trilipix indication ...

Trilipix is a peroxisome proliferator receptor alpha (PPARa) activator indicated:
• In combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal (1.1).
• As monotherapy to reduce TG in patients with severe hypertriglyceridemia (1.2).
• As monotherapy to reduce elevated LDL-C, Total-C, TG and Apo B, and increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia (1.3).

Limitations of use: No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.

General Considerations For Treatment: Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in a 2 large, randomized controlled trial of patients with type 2 diabetes mellitus.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf