FDA panel unanimously backs expanding use of Amarin's heart drug Vascepa

(Reuters) – A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc’s fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.

The panel on Thursday voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for the company which has only one drug, Vascepa, in the market.

The company’s shares were halted ahead of the vote.

The FDA, which is slated to announce its final decision on the label expansion by Dec. 28, is not mandated to follow the recommendation of the panel, but generally does.

Vascepa, a highly purified omega-3 fatty acid derived from fish oil, won U.S. approval in 2012 to lower high levels of triglycerides, a type of blood fat that can increase the risk of heart disease.

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

In the United States, cardiovascular disease leads to one in every three deaths, with annual treatment costs in excess of $500 billion, according to Amarin.

Patients with high triglycerides, who also have complications like diabetes, are especially vulnerable to recurring cardiovascular complications.

The drug has earlier won the vote of confidence from major medical communities including the American Heart Association, American Diabetes Association as a treatment to help lower the chance of heart attacks and strokes.



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