December 13, 2019
Amarin's Vascepa Approved to Reduce Cardiovascular Risk
December 13, 2019—Amarin Corporation plc announced that the FDA has approved a new indication and label expansion for Vascepa, the company’s icosapent ethyl capsules. The approval for the supplemental new drug application was supported by findings from the REDUCE-IT study. The company will promptly launch Vascepa in the United States for this new preventative care indication.
The company advised that the new indication for Vascepa is incremental to the indication it was initially FDA approved for: as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
According to the company, Vascepa is now 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 (≥150 mg/dL) and (1) established cardiovascular disease or (2) diabetes mellitus and two or more additional risk factors for cardiovascular disease.”
Deepak L. Bhatt, MD, Lead Investigator of the REDUCE-IT study, commented in the company’s announcement, “The FDA approval of icosapent ethyl as an addition to statin therapy to reduce the risk of cardiovascular events is a major milestone in cardiovascular prevention. Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly three decades ago. Many patients stand to benefit from this historic advance in care.” Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.
In the global REDUCE-IT cardiovascular outcomes study, approximately 28% of patients in the control arm treated with statins and other contemporary therapy but not treated with Vascepa experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction, stroke, coronary revascularization, unstable angina requiring hospitalization, or cardiovascular death. In November 2018, Dr. Bhatt presented the results from the REDUCE-IT trial at the American Heart Association 2018 Scientific Sessions in Chicago, Illinois, which were later published in The New England Journal of Medicine (2019; 380:11–22).
The company stated that this MACE occurrence demonstrates that there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care. For those adult patients in this group who have elevated triglycerides (≥ 150 mg/dL) and established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease, Vacepa is approved to help reduce this persistent cardiovascular risk.
An exploratory analysis of the REDUCE-IT study published in March 2019 by Bhatt et al in Journal of the American College of Cardiology examined total (first and subsequent) cardiovascular events over a period of approximately 5 years. The investigators found that patients taking Vascepa, on average, experienced one fewer MACE per six patients studied, representing a 30% risk reduction in total MACE compared to placebo (2019;73:2791–2802).