Amarin Corp Plc (AMRN)

[Atom0aks]

Thus, I'm still unsure Amarin, presenters, FDA and panelists, were using the terms Primary prevention and Secondary prevention uniformly.

Primary and secondary prevention patients as defined by the REDUCE-IT study can be summarized as,

Primary: Patients with diabetes and risk factors for cardiovascular disease (i.e. prevention of cardiovascular disease)

Secondary: Patients with cardiovascular disease (i.e. prevention of additional cardiovascular disease)

As you pointed out, the REDUCE-IT definition of primary prevention patients is a very narrow definition of primary prevention and is a reason for the AdCom as shown by this discussion,

3. 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 lowdensity 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

Source: https://www.fda.gov/media/132472/download

The discussion that ensued over how to incorporate these populations into the label is probably why it sounded like these definitions were not being used uniformly.