Icosapent to lower elevated triglyceridesFebruary 6, 2020
Icosapent ethyl (Vascepa) has been granted approval as an adjunctive therapy for the reduction of cardiovascular event risks among adults with triglyceride levels elevated to 150 mg/dL or higher.
Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.
Icosapent was initially approved in 2012 for adults with severe triglyceride levels. This supplement application received Priority Review.
An FDA advisory committee voted unanimously to recommend the approval, largely on the basis of the so-called REDUCE-IT trial that demonstrated a 25% reduction in total CV events after some 5 years of follow-up.
The efficacy and safety were established in a study with 8,179 patients who were either 45 years and older with a documented history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease.
Icosapent is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy, Amarin Pharma said.