The Endocrinologic and Metabolic Drugs Advisory Committee declined to recommend an expanded indication for Amarin Pharmaceutical’s Vascepa (icosapent ethyl). The panel voted 9-2 yesterday against approval of the drug for the proposed new indication that would allow it to be available to a much broader patient population.

Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dl). The new indication would include individuals who have elevated triglycerides (>200 mg/dl) and existing cardiovascular disease (CVD) or those who are susceptible to CVD.

Vascepa is a purified ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil. EPA, along with docosahexaenoic acid (DHA) and alpha-linolenic acid are collectively referred to as omega-3 fatty acids.

The supplemental new drug application (sNDA) for the indication was based on the ANCHOR trial, which demonstrated that Vascepa did in fact lower triglycerides in the target patient population. However, FDA review raised some issues that made it difficult to precisely measure Vascepa’s triglyceride-lowering effect. Furthermore, the panel was not convinced that lowering triglycerides would automatically lead to a reduced risk of coronary heart disease or death. Dr. David Cooke, clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist, said it “has not yet been proven” that Vascepa, or any medication that lowers blood fats, except statins, decreases cardiovascular risk.

The panel recommended waiting for the results of the large ongoing Vascepa outcomes trial,  REDUCE-IT, before coming to a conclusion. This ongoing trial has enrolled more than 6,000, out of an eventual 8,000, patients and is expected to shed light on whether Vascepa actually cuts cardiovascular risk. Amarin said the trial should be completed in 2016.

The FDA is not bound to follow the recommendations of its advisory panels but typically does.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Interested in learning about ISS’ expert approach to Advisory Committee Meetings? Click below in order to find out for yourself!