FDA panel backs fish oil-derived drug

A US Food and Drug Administration (FDA) panel has recommended the use of a fish oil-derived drug as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.

The drug Vescepa, produced by US pharmaceutical company Amarin, was a highly purified form of omega-3 fatty acid that won US approval in 2012 to lower higher levels of triglycerides, Reuters reported on 14 November.

A late stage trial last year found that Vascepa, when administered to patients on cholesterol-lowering statins, cut the combined rate of heart attacks, strokes and other cardiovascular events by 25% compared to a placebo.

“There is no doubt that this is a medication that could benefit a substantial portion of the USA and meets an unmet need,” said panel member Dr Jack Yanovski of the National Institutes of Health.

Some panel members were unconvinced of the drug’s effectiveness in reducing cardiac events in patients who had not had strokes or heart attacks.

Some patients in the trial reported slightly higher risk of bleeding and a small increase in irregular heart rhythm, which the panel members suggested highlighting on the drug’s label.

In the USA, cardiovascular disease led to one in three deaths. An expanded label could open up market access to up to 15M Americans with high triglycerides and other cardiovascular risk factors, despite being on statin treatment, Reuters wrote.

The FDA was not mandated to follow the recommendation of the panel, but generally did. The decision on the label expansion was set to be made on 28 December.