December 13, 2019
4 min read

FDA approves CV event risk reduction indication for icosapent ethyl

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Deepak L. Bhatt

The FDA on Friday approved the use of icosapent ethyl as an adjunctive therapy to reduce the risk for CV events among adults with elevated triglyceride levels, according to an agency press release.

Patients must also have either established CVD or diabetes and two or more additional risk factors for CVD.

Icosapent ethyl (Vascepa, Amarin) is the first FDA-approved drug to reduce CV risk among adults with elevated triglycerides as an add-on to maximally tolerated statin therapy.

The drug first netted approval in July 2012 for the reduction of triglycerides in adults with severe hypertriglyceridemia.

In November, the expanded indication to reduce risk for CV events was discussed during an Endocrinologic and Metabolic Diseases Advisory Committee of the FDA meeting. As Healio previously reported, the committee voted 16-0 in favor of the safety and efficacy of icosapent ethyl, based on available data, to support this indication.

“First, the unanimous 16-0 vote by the independent FDA advisory committee and now this formal FDA label expansion for CV risk reduction really endorse the strength of our findings from REDUCE-IT regarding icosapent ethyl,” Cardiology Today Editorial Board Member Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, told Healio.

The FDA evaluated data from REDUCE-IT, which included 8,179 adults aged 45 years and older with a history of CAD, cerebrovascular disease, carotid artery disease and/or peripheral artery disease, or adults aged 50 years and older with diabetes and additional risk factors for CVD. REDUCE-IT demonstrated that icosapent ethyl was superior to placebo for reducing risk for ischemic events in patients with elevated triglycerides at high CV risk despite statin therapy. In March, new data from the REDUCE-IT trial demonstrated a 30% reduction in total ischemic events, including first and subsequent events, in high-risk patients with elevated triglycerides.

“The independent Institute for Clinical and Economic Review group found icosapent ethyl to be highly cost-effective, and William Weintraub, MD, just presented our REDUCE-IT patient-level cost-effectiveness data at the American Heart Association Scientific Sessions, finding icosapent ethyl to be ‘dominant,’ or cost-saving, in the majority of cases. That is something that is quite rare in cost-effectiveness research,” Bhatt said in an interview. “Multiple professional society guidelines such as the American Diabetes Association, European Society of Cardiology/European Atherosclerosis Society and National Lipid Association, have already incorporated the REDUCE-IT findings for secondary prevention and diabetic primary prevention, and now there is an FDA label that also backs that approach. So, at this time, the key challenge is to now identify and treat appropriate patients — a large population that stands to benefit substantially from this novel therapeutic approach.”

In a statement released Friday, John F. Thero, president and CEO of Amarin, said the expanded indication for icosapent ethyl offers a new option for people with persistent CV risk despite the use of statins with other contemporary standard-of-care therapies.

“We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients,” Thero said in the release. “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.”

Michael Miller

Healio also spoke with Michael Miller, MD, professor of cardiovascular medicine, epidemiology and public health and director of the Center for Preventive Cardiology at University of Maryland School of Medicine in Baltimore, about this FDA approval. He said, “This is a huge victory for so many of our patients because nearly one out of every three men and women in the U.S. has a triglyceride of at least 150 mg/dL, and millions of these patients have CVD or have diabetes plus multiple CV risk factors.”

Icosapent ethyl’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil.

In clinical trials, icosapent ethyl was associated with an increased risk for atrial fibrillation requiring hospitalization. The incidence of AF was greater among patients with a history of AF or atrial flutter. Icosapent ethyl was also associated with an increased risk for bleeding events. The incidence of bleeding was higher among individuals taking other medications that increase the risk for bleeding, such as aspirin, clopidogrel or warfarin.

The FDA noted that people with allergies to fish or shellfish should be advised about the potential for allergic reactions. The most common adverse effects reported in the clinical trials for icosapent ethyl were musculoskeletal pain, peripheral edema, AF and arthralgia. – by Regina Schaffer, with additional reporting from Darlene Dobkowski

For more information:

Deepak L. Bhatt, MD, MPH, can be reached at; Twitter: @dlbhattmd.

Michael Miller, MD, can be reached at Cardiovascular Medicine, 110 South Paca St., Suite 7N-124, Baltimore, MD 21201; email:; Twitter: @mmillermd1.

Disclosures: Bhatt reports he received research funding from Amarin to Brigham and Women’s Hospital for his role as a study chair and is principal investigator of the REDUCE-IT trial. Miller reports he is a steering committee member for the REDUCE-IT trial and a scientific advisor for Amarin. Thero is president and CEO of Amarin.