FDA Approves Icosapent Ethyl as Adjunctive CV Risk Reduction Therapy


The approval makes it the first indicated by the FDA for cardiovascular risk reduction among patients with elevated triglyceride levels, as an add-on to maximally tolerated statin therapy.


The US Food and Drug Administration (FDA) has approved icosapent ethyl (Vascepa) as an adjunctive therapy for the reduction of cardiovascular event risks among adults with triglyceride levels elevated to 150 mg/dL or higher.

The approval makes the Amarin therapy the first indicated by the FDA for cardiovascular risk reduction among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy.

The safety and efficacy of icosapent was evidenced in the 8179-patient REDUCE-IT trial, assessing the therapy in patients aged 45 years and older with a clinical history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease. Invesitgators reported patients who received therapy were significantly less likely to experience a cardiovascular event, such as a stroke or heart attack.

In a recent interview with MD Magazine®, lead REDUCE-IT investigator Deepak Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and professor of medicine at Harvard Medical School, said he hopes clinicians find the pivotal results to be "practice-changing" for at-risk patient care.

"Certainly, we saw large degrees of benefit across a variety of different endpoints including a 20% risk reduction in cardiovascular death that was statistically significant—also, significant reductions in myocardial infarction, stroke, hospitalization for unstable angina, revascularization procedures," Bhatt said. "So, the number of events prevented—in terms of the population treated—was really quite substantial and, therefore, I think physicians will view the results as practice changing once they become familiar with the trial results."

In previous trials, icosapent ethyl has been associated with an increased risk of atrial fibrillation (AFib), requiring hospitalization. The incidence of AFib has been observed to be greater among patients with a previous history of such events. The therapy, which has an active ingredient of omega-3 fatty acid, was also associated with an increased risk of bleeding events. The incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel, or warfarin during treatment.

Icospaent was initially approved in 2012 for adults with severe triglyceride levels.

In a statement accompanying the approval, John Sharretts, MD, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, acknowledged the need for additional cardiovascular disease risk-reduction therapy in the US.

"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," Sharretts said.

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