FDA approves new and expanded indication for Vascepa in patients with elevated triglyceride levels and CV risk.- Amarin

Amarin Corp announced that the FDA has approved a new indication and label expansion for Vascepa (icosapent ethyl) capsules as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (at least 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.

In the global REDUCE-IT cardiovascular outcomes study, approximately 28 percent of patients in the control arm treated with statins and other contemporary therapy but not treated with Vascepa experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction (heart attack), stroke, coronary revascularization, unstable angina requiring hospitalization or cardiovascular death. As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care. For those adult patients in this group who have elevated triglycerides (TG) at least 150 mg/dL and established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease, Vascepa is the first drug approved to help reduce this persistent cardiovascular risk. In a published exploratory analysis of the REDUCE-IT study, examining total (first and subsequent) cardiovascular events over a period of approximately five years, patients taking Vascepa on average experienced one fewer MACE per six patients studied, representing a 30 percent risk reduction in total MACE compared to placebo.

The overall rates of adverse events and serious adverse events in the 5-year REDUCE-IT study were similar between Vascepa-treated patients and placebo-treated patients. As reflected in Vascepa's expanded label and described below, Vascepa has been associated with increased risks of bleeding and atrial fibrillation/flutter, the latter being more prevalent in patients with a previous history of atrial fibrillation or flutter.

Comment: this new indication for Vascepa is incremental to its indication for which it was initially FDA approved, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.