Amarin Corp Plc (AMRN)

[Laurent Maldague]

Good discussion. One of Germany's criticism was that LDL levels should have been more aggressively lowered in Reduce-IT (ideally <55mg/dL for very high risk to match European guidelines).

I believe Amarin asked Bhatt to help further address that criticism, hence this presentation earlier at ACC 2024 back in April:
https://www.biospace.com/article/releases/new-reduce-it-analyses-show-vascepa-vazkepa-icosapent-ethyl-benefit-in-high-risk-cardiovascular-disease-patient-subgroups/

"Among statin-treated REDUCE-IT patients with baseline LDL-C data, 1,058 (12.9%) had LDL-C <55 mg/dL and 7,117 (87.1 %) had LDL-C ≥55 mg/dL. The primary outcome rate among patients with LDL-C <55 mg/dL was 16.2% in the IPE group and 22.8% in the placebo group, HR 0.66 (95% CI 0.50-0.87; P=0.003). Findings were consistent in the LDL-C ≥55 mg/dL subgroup, with rates of 17.4% in the IPE group and 21.9% in the placebo group, HR 0.76 (95% CI 0.69-0.85; P<0.0001). No significant interaction by baseline LDL-C was observed."

We all already intuitively understand that V has no true comparator, because it's not an LDL-C therapy, and only has a marginal impact on LDL-C (about -5% reduction in ANCHOR). The reduce-it analysis shows that further lowering LDL-C does not make V's benefit wane (if anything, it's slightly more pronounced).