During the FDA review of the data, Dr. Mary Dunne Roberts, a clinical reviewer in the FDA’s Division of Metabolism and Endocrinology Products, referred to the ongoing debate over whether drug-induced modulation of TGs results in improved CV outcomes. Results of recent CV outcome trials with fenofibrate and niacin have raised questions about whether targeting lipids and lipoproteins other than LDL-cholesterol results in incremental cardiovascular benefits in patients on optimal statin therapy and LDL-C control, she pointed out.
In 2011, Amarin launched REDUCE-IT, which is comparing the impact of treatment with 4 g of Vascepa per day to placebo added to statin therapy in 8,000 patients with CV disease or CV risk, on a composite endpoint of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, and unstable angina requiring hospitalization. At the beginning of October, about 6,000 patients with a median TG level of 202 mg/dL had been enrolled. The company expects the study to be completed in 2016 or 2017.
Panelists agreed that REDUCE-IT was a well-designed, important study, with an appropriate group of patients, which should provide answers about whether CV outcomes will be improved with Vascepa, and they were encouraged that the study was underway.
Panelist Dr. Peter Wilson, professor of medicine in the cardiology division of Emory University, Atlanta, said that there was no need to prescribe more agents "because we think they work," and he expressed concern about overprescribing. "There is already overuse of some omega-3s without proven benefit. We need the trial results in hand to guide decisions."
Vascepa is one of two omega-3 fatty acid formulations approved by the FDA; the other is Lovaza, a combination of EPA and docosahexaenoic acid (DHA). Many omega- 3 fatty acid products are available over the counter, with variable combinations and strengths.
The FDA usually follows the recommendations of its advisory panels. Members have been cleared of potential conflicts; occasionally, a panelist is given a waiver for a potential conflict, but not at this meeting.