FDA approves expanded indication for Amarin’s Vascepa

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FDA approves expanded indication for Amarin’s Vascepa

By Sandra Levy - 12/30/2019

Amarin has received the Food and Drug Administration’s blessing for a new indication and label expansion for Vascepa (icosapent ethyl) capsules.

Vascepa 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 (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.

It is estimated that millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy.

“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 John Thero, Amarin president and CEO.

Thero continued, “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. We look forward to helping educate physicians and patients on the value of Vascepa. The expanded indication and related clinical study labeling is broadly worded, informative on the many effects of Vascepa and will empower physicians with critical information to help them apply their clinical judgment in addressing cardiovascular disease risk for patients in need.”

Vascepa also is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

“In achieving this expanded indication, Amarin appreciates the FDA’s guidance in the design and conduct of multiple clinical trials of Vascepa across the past decade and for its diligence in reviewing the results of these studies,” said Steven Ketchum, Amarin senior vice president and president, research and development and chief scientific officer. 

"The FDA recognizes there is a need for additional medical treatments for cardiovascular disease," said John Sharretts, acting deputy director of the division of metabolism and endocrinology products in the FDA's center for drug evaluation and research. "Today's approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events."


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