European Commission approval for icosapent ethyl to reduce CV risk

Icosapent ethyl has received approval from the European Commission (EC) to reduce the risk of CV events in high risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor.

The EC approval is based on efficacy and safety data from the REDUCE-IT trial [1]. The REDUCE-IT trial enrolled >8000 patients who were at high risk of heart attack, stroke or other MACE, despite being on statin therapy. Patients had LDL-C controlled to between 41-100 mg/dL by statin therapy, triglycerides between 135-499 mg/dL and either established CVD or diabetes mellitus and at least one other risk factor for CVD. Patients were randomized to icosapent ethyl (4g daily) or placebo. The median follow-up period was ~5 years. The results showed a 25% relative risk reduction of first occurrence of MACE with icosapent ethyl compared to placebo (P<0.001).

The 2019 ESC/EAS Dyslipidemia Management Guidelines recommend the use of icosapent ethyl in high-risk, statin-treated patients [2].

References

Source: Press release Amarin Corporation, March 30, 2021