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FDA Considering Amarin Study Request

Fri, 12/20/2013 - 9:55am
The Associated Press


Federal regulators appear to be considering a proposal by Amarin in regard to the structure of a drug study that could lead to wider uses for its fish-oil pill, sending shares of biopharmaceutical up 25 percent before the opening bell.

The drug Vascepa is a prescription-strength form of an omega-3 fatty acid. It is Amarin's only product and it was approved last year for a relatively narrow use in patients with unusually high triglyceride levels.

The company said Friday that the Food and Drug Administration is delaying its decision, which had been expected by Friday, so that it could resolve a question about study design.

Amarin had asked the FDA to reinstate a special protocol assessment, which is an agreement between the company and the agency over the design of research.

FDA advisers voted 9-2 against recommending broader use two months ago, sending company shares plunging 74 percent in October. A majority of panelists said that while Vascepa significantly lowers fat levels, it is unclear whether that actually translates into fewer heart attacks. The panel said the FDA should delay a decision on expanded use until Amarin completes a study of patient heart attack rates.

The drug maker has said that it believes FDA advisers would have recommended a broader use for the drug if the special protocol assessment had been in place.

Amarin believes the drug can be used safely by patients with high triglyceride levels and heart disease that are already taking a statin drug to help control their cholesterol.

The FDA expects to make a decision on the special protocol assessment by Jan. 15.

Shares of the Dublin company rose 40 cents to $1.99 in premarket trading.

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