MONDAY, Dec. 16, 2019 (HealthDay News) -- Vascepa (icosapent ethyl) has received the first approval for an adjunctive therapy for reducing the risk for cardiovascular events in adults with elevated triglyceride levels, the U.S. Food and Drug Administration announced Friday.
The drug, which was approved in 2012 for adults with severe triglyceride levels, received extended approval for adults with triglyceride levels of 150 mg/dL or higher who also have cardiovascular disease or diabetes and at least two other risk factors for cardiovascular disease. Vascepa, which is taken orally, is indicated as an add-on therapy to maximally tolerated statin therapy.
Vascepa's approval was based on data from the REDUCE-IT trial of 8,179 patients. The study population included patients aged 45 years and older with a history of coronary artery, cerebrovascular, carotid artery, and peripheral artery disease and those aged 50 years and older with diabetes and risk factors for cardiovascular disease. Data revealed that patients taking Vascepa on average experienced one fewer major adverse cardiovascular event per six patients studied during approximately five years -- which translated to a 30 percent reduction in the risk for total major adverse cardiovascular events compared with placebo.
Clinical data revealed that Vascepa was associated with an increased risk for atrial fibrillation or atrial flutter, especially in patients with a history of these conditions. Researchers also found an increased risk for bleeding events, particularly in patients who were also taking aspirin, clopidogrel, or warfarin. Patients with allergy to fish or shellfish could have an allergic reaction to Vascepa and should be advised of this risk. The most commonly reported side effects of Vascepa were musculoskeletal pain, peripheral edema, atrial fibrillation, and arthralgia.
Approval was granted to Amarin Pharma.
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