FDA approves new indication for icosapent ethyl in high CV risk patientsNews - Dec. 17, 2019
The US Food and Drug Administration (FDA) has approved a new indication for icosapent ethyl to reduce risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization. It is now approved as an adjunct to maximally tolerated statin therapy in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established CVD or T2DM with ≥2 additional CV risk factors.
In the REDUCE-IT CV outcomes trial, treatment with icosapent ethyl reduced major adverse cardiovascular event (MACE), a composite of MI, stroke, coronary revascularization, unstable angina requiring hospitalization or CV death, when compared to those taking placebo in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established CVD or T2DM with ≥2 additional CV risk factors. In an exploratory analysis of REDUCE-IT, patients taking icosapent ethyl compared to placebo had a 30% risk reduction in total MACE (first and subsequent events) after a period of five years.
Overall rates of adverse events and serious adverse events in REDUCE-IT were similar in the icosapent ethyl group and the placebo group. Icosapent ethyl has been associated with increased risk of bleeding and atrial fibrillation/flutter.
Icosapent ethyl capsules are comprised solely of the active ingredient icosapent ethyl (IPE), a form of eicopentaenoic acid. The initial indication for icosapent ethyl was for use as an adjunct therapy to diet to reduce TG levels in adult patient with severe (≥500 mg/dL) hypertriglyceridemia.