Amarin Shares Plunge As FDA Rescinds Special Protocol Assessment Agreement
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5:53 PM ET 10/29/13 | Dow Jones
By Anna Prior
Amarin Corp. (AMRN) said the U.S. Food and Drug Administration has rescinded a special protocol assessment agreement for a study related to the biotechnology company's supplemental new drug application for its cholesterol drug Vascepa, which an FDA advisory committee voted against earlier this month.
Shares tumbled 15% to $1.79 in recent after-hours trading. Through the close, the stock has plunged 74% since the start of the year.
The company said Tuesday in a regulatory filing that the FDA has determined that "a substantial scientific issue" essential to determining the effectiveness of Vascepa in the studied population was identified after testing began.
Specifically, the FDA said results from several outcome trials failed to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels, said Amarin.
As such, the FDA no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with certain serum triglyceride levels, said the company.
Amarin said it is working with the FDA to schedule a Type A meeting to discuss with the FDA's notice.
Amarin is seeking approval to expand the market for Vascepa, a fish oil-derived drug that lowers patients' blood-fat levels. However, the FDA's endocrinologic and metabolic drugs advisory committee earlier this month voted 9 to 2 against Vascepa's approval for use as an adjunct to diet for the treatment of adults with high triglycerides with mixed dyslipidemia.
The committee's decision came after the FDA released an assessment of the drug that cast doubt about whether the agency would approve the expanded use. The briefing document said advisory committee members should consider that recent large cardiovascular outcome trials "have failed to demonstrate a reduction in residual cardiovascular risk with non-statin lipid-altering treatment."
The FDA is scheduled to complete its regulatory review on the drug on Dec. 20.
Write to Anna Prior at anna.prior@wsj.com
