Updated with new information.
BEDMINSTER, NJ (
) --The U.S. Food and Drug Administration on Thursday approved a prescription fish-oil pill from
that will be used to treat patients with very high levels of triglycerides, a type of fat found in blood.
Amarin's newly approved drug Vascepa is made from ultra-purified ethyl EPA, an omega-3 fatty acid commonly found in fish. An FDA spokesperson confirmed the approval.
An FDA decision on whether Vascepa will be granted five years of market exclusivity as a New Chemical Entity (NCE) has not been announced and won't likely be public until August, Amarin said in a statement.
Shares of Amarin were halted ahead of the Vascepa approval announcement at $15.31.
When taken daily at its highest dose, Vascepa lowered triglyceride levels by 33% compared to a placebo in a phase III clinical trial that enrolled patients with very high baseline levels (greater than 500 mg/dl) of the blood fat. Vascepa also did not cause a significant increase in LDL, or "bad" cholesterol.
Vascepa will compete against a similar prescription-grade fish oil pill marketed by
(GSK - Get Report)
known as Lovaza, which generates about $1 billion in annual sales.
Amarin is planning on a Vascepa commercial launch in the first quarter of 2013. Who launches the drug is still being determined. Amarin said it is still pursuing three options: A sale of the company, a partnership or marketing the drug on its own.
--Written by Adam Feuerstein in Boston.
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