FDA Expert Panel Approves Expanded Indication For Fish-Oil Drug

But the advisory panel didn't go for a primary prevention OK for Vascepa
Peter Wehrwein

An FDA advisory panel voted 16-0 in favor of an expanded indication for Vascepa (icosapent ethyl) capsules on Thursday.

Vascepa, which is pharmaceutical grade fish oil, is currently approved as an add-on therapy to reduce triglycerides in people with severe hypertriglyceridemia. Based on positive results from the REDUCE-IT, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously yesterday to expand that indication to include cardiovascular risk reduction among adult patients with high triglycerides who are already on statins. 

Commentators noted that negotiations between the agency and the manufacturer, Amarin, about the wording  of the label likely to be intense. According to Stat, Vascepa is on track to bring the Irish company about $500 million in sales revenues this year.

The FDA usually follows the guidance of its advisory panels but isn't required to. A final decision on this broader secondary prevention indication is expected before the end of the year.

One open question is whether the indication for Vascepa might be expanded even further so it would include primary prevention, although, of course, nothing prevents doctors from prescribing Vascepa off-label for that purpose. 

The data for secondary prevention were "overwhelmingly convincing" but the primary prevention data "wholly unconvincing," said panelist James de Lemos, MD, of UT Southwestern Medical Center in Dallas., according to MedPage Today's account of the meeting. After votubf for expanded indication, de Lemos said he would limit this indication to CVD risk reduction in patients with established atherosclerotic CVD.

"Several panelists expressed a reluctance to see the drug recommended for a primary prevention group—diabetes and at least one major cardiovascular risk factor but no established CV disease—but secondary prevention among patients with established cardiovascular disease was a no-brainer for most," wrote John Carroll of Endpoints News yesterday.