Replies to post #231339 on Amarin Corp Plc (AMRN)

[bfost]

sts - if you are convinced AMRN asked the FDA for a label excluding statins there is nothing else I can say at this point. EOM.

[Atom0aks]

Doc, I copied that directly from the AC voting question PDF - AMRN did not ask for a label from FDA that contains the word "statins"

They did.

From your previous post,

DISCUSSION: The applicant has proposed an indication for cardiovascular risk reduction in adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for cardiovascular disease (CVD), without regard for age, diabetes status, or adequacy of low-density lipoprotein (LDL-C) control. Please discuss the population – beyond the subset of patients with established CVD – for whom you believe the data from REDUCE-IT provide evidence of cardiovascular risk benefit, addressing the following factors:
• Age
• Diagnosis of diabetes
• Additional risk factors for CVD
• Plasma LDL-C concentration
• Plasma triglyceride concentration
• Intensity of statin therapy
• Any other factor you believe is important

You can double check the final transcript, but some of the advisory committee members had questions regarding this discussion topic and so someone verified that patients will be on statin.