Amarin Corp Plc (AMRN)

[drrc1949]

The whole point of taking Vascepa is to improve cardiac outcomes in a patient population. However, the proposed indication that should have been reviewed by the panel was as follows:

Vascepa (icosapent ethyl) is indicated as an adjunct to diet and exercise and in combination with a statin to reduce triglyceride TG, non-HDL-C, ApoB, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.

Nothing in there about Vascepa improving CVD for the indication currently under review. The references to CHD are used merely in description of the patient population being studied.