FDA Approves Icosapent Ethyl for Reducing CVD Events
The prescription-grade fish oil received the expanded claim following the positive REDUCE-IT results.
The US Food and Drug Administration has expanded the label and indication for icosapent ethyl (Vascepa; Amarin), stating that the prescription-grade omega-3 fatty acid may be prescribed for reducing the risk of major cardiovascular events based on the results of REDUCE-IT.
Specifically, icosapent ethyl is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of MI, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglycerides (> 150 mg/dL) and established CVD or diabetes mellitus plus two additional CVD risk factors.
Last month, members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously in favor of the CVD-reduction indication following a review of REDUCE-IT, a large-scale cardiovascular outcomes trial.
As reported by TCTMD previously, the REDUCE-IT investigators showed that adding icosapent ethyl to maximally tolerated statin therapy reduced the risk of major cardiovascular events by 25% compared with placebo. In the study, the addition of icosapent ethyl reduced the risk of cardiovascular death, MI, or stroke by 26% compared with placebo.
Several major societies have already made room in various guidelines, scientific statements, and advisories for icosapent ethyl, including the American Diabetes Association, American Heart Association, National Lipid Association, and European Society of Cardiology/European Atherosclerosis Society.
Amarin. Amarin receives FDA approval of Vascepa (icosapent ethyl) to reduce cardiovascular risk. Published and accessed on: December 13, 2019.
- Amarin sponsored the REDUCE-IT study.