Vascepa FDA approval : New Jersey-based Amarin has secured approval from the US Food and Drug Administration (FDA) for a new indication and label expansion for Vascepa (icosapent ethyl) capsules.
The FDA has now approved Vascepa as an adjunctive (secondary) therapy to cut down the risk of cardiovascular events in adults having elevated triglyceride levels, a type of fat in the blood, of 150 milligrams per deciliter or higher.
According to the FDA, patients should also have their established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease to be eligible for taking Vascepa. The regulator advises patients to continue physical activity and stay on a healthy diet.
Vascepa is now the first approved drug by the FDA to lower cardiovascular risk in patients having elevated triglyceride levels as an add-on to maximally tolerated statin therapy. As per the FDA, statins are drugs that are used for the treatment of elevated cholesterol levels and lower the risk of cardiovascular events.
The efficacy and safety of Vascepa were established in a study that enrolled 8,179 patients who were 45 years and older with a documented history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and more with diabetes and additional risk factors for cardiovascular disease.
Patients treated with Vascepa were significantly less probable to experience a cardiovascular event like stroke or heart attack, said the FDA based on the study results. The oral drug’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, extracted from fish oil.
John F. Thero – president and CEO of Amarin, commenting on the latest Vascepa FDA approval, said: “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 was approved initially by the FDA in 2012 for adults having severe triglyceride levels.
John Sharretts – acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA Center for Drug Evaluation and Research, commenting on the latest Vascepa FDA approval, said: “The FDA recognizes there is a need for additional medical treatments for cardiovascular disease.
“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.”