An FDA advisory committee said "No" to an expansion of the indication for Amarin's prescription EPA-only fish oil, icosapent ethyl (Vascepa).
The agency's voted 9-2 against recommending approval of the drug to be used as an adjunct to statin therapy to lower triglycerides, non-HDL cholesterol, apolipoprotein B, LDL cholesterol, total cholesterol, and very-LDL cholesterol in adults with mixed dyslipidemia and either established coronary heart disease or a coronary heart disease equivalent (another form of atherosclerotic disease, diabetes, or a collection of risk factors conferring more than a 20% risk of coronary heart disease in the next 10 years).
Vascepa was approved in July 2012 as monotherapy for reducing triglyceride levels in patients with levels of at least 500 mg/dL in conjunction with a lipid-lowering diet and exercise based on the results of the .
The supplemental new drug application for the expanded indication was supported by results from the , which showed that the drug significantly reduced fasting triglyceride levels through 12 weeks when used in patients who had mixed dyslipidemia and a high cardiovascular risk, were on stable statin therapy, and had fasting triglyceride levels of 200 to less than 500 mg/dL.
The committee members decided those data were not compelling enough to support the expanded indication before seeing the results of the ongoing . That trial includes high-risk patients with mixed dyslipidemia who are taking statins and compares the effects of Vascepa versus placebo on a composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina. Results aren't expected until November 2016.
Two issues raised in the released before the meeting worked against the expanded indication.
First, patients in the placebo group -- who received mineral oil -- had some negative changes in lipids during the ANCHOR trial, including a median 9% increase in LDL cholesterol. The findings "at least suggest the possibility that mineral oil may not be biologically inert," according to the FDA reviewer. Thus, the benefits of Vascepa could have been overestimated.
Second, there is a lack of evidence that cardiovascular outcomes are improved with fish oil -- or any other non-statin lipid-modulating agents for that matter.
So it appears that the results of the REDUCE IT trial, although still years away, will be needed before the FDA grants an expanded indication to Vascepa.