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Amarin's Vascepa Gets FDA Approval For Expanded Use, Shares Up 5%

Shares of Amarin Corp. (AMRN) jumped 5% on extended trading session after the company said it received approval to market its drug Vascepa for cardiovascular problems.

Amarin said the U.S. Food and Drug Administration has approved a new indication and label expansion for Vascepa capsules. It is now the first and only drug approved by the FDA "as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease."

"We at Amarin are excited and gratified to now have the opportunity to introduce Vascepa as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies," said CEO John Thero.

"We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin."

Amarin reaffirmed its intention to promptly launch Vascepa in the United States for this important new preventative care indication.

AMRN closed Friday's trading at $24.12, up $1.13 or 4.92%, on the Nasdaq. The stock further gained $1.58 or 6.55% in the after-hours trade.

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