Amarin Corp Plc (AMRN)

[wmartin100]

From the FDA Briefing:


"...discuss the population – beyond patients with established CVD – that should be included in the indication. Options could include, but are not limited to:

1• adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for CVD, without regard for age, diabetes status, or adequacy of LDL-C control (proposed by applicant).

2• Risk Cohort 2, which represented 30% of the REDUCE-IT trial population and comprised patients aged 50 years and older without established CVD, who had diabetes, one or more additional risk factors for CVD, and hypertriglyceridemia despite optimized statin therapy to achieve LDL-C less than 100 mg/dL."


AMRN proposed labeling similar to #1, FDA is countering with labeling #2 and asking the panel what they think about it.

#1 is broader as it includes people with no actual CVD, but with risk factors for CVD. Still, a label that includes all those with established CVD would be pretty broad. I don't know enough to immediately calculate the economic value of #1 over #2 to AMRN, but the market seems to be taking this positively. Today's price action may have more to do with the marginalizing of the MO issue, than with label variations.