Amarin Corp Plc (AMRN)

[HDGabor]

If it will not be a CRL, we could see something like this::

Possible label change:
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VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia.

VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet and in combination with a statin to reduce triglyceride (TG) levels, in adult patients with mixed dyslipidemia = 200 mg/dL and <500 mg/dL).

Limitations of Use:
•The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
•The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia and mixed dyslipidemia has not been determined.

and 14.1 Mixed dyslipidemia (details and data of ANCHOR study)
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Maybe, some (all) of the following will be included: non-HDL-C, Apo-B, TC, and VLDL-C, but definitely not the LDL-C.

ANCHOR indication:
“Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia
VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.”

Crestor label contains:
“Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C (1.1)