FDA Approves Vascepa as Add-on Therapy to Reduce CV Risk

The FDA on Friday approved icosapent ethyl, sold as Vascepa by Amarin, as an add-on therapy to reduce the risk of cardiovascular events for adults with high triglyceride levels.

The agency said this was the first such approval, as the purified omega-3 fatty acid is now approved to be used alongside statins to treat elevated cholesterol levels and cut the risk of events such as heart attacks or strokes. The drug was first approved in 2012 for patients with elevated triglycerides.

“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” John Sharretts, MD, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

The label change covers patients with triglycerides of 150 mg/dL or higher; they must have established cardiovascular disease or diabetes with 2 additional risk factors.

FDA’s action comes more than a year after presentation of results for REDUCE-IT, which showed the purified oral fish oil capsule reduced the risk of initial cardiovascular events by 25%. Subsequent results presented in March at the American College of Cardiology showed the pill could reduce first and subsequent events by 30%.

“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,” lead REDUCE-IT investigator Deepak L. Bhatt, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School, said in a statement. “Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly 3 decades ago. Many patients will benefit from this historic advance in care.”

One of the regulatory issues surrounding Vascepa has been a lack of explanation for how the drug works. Last month, a study presented at the American Heart Association suggested that the therapy has an effect on coronary plaques, and this could be a key to its preventive effects on cardiovascular events.

The lack of clarity was reflected in FDA’s statement, which said, “The mechanisms of action that contribute to reduced cardiovascular events among patients taking Vascepa are not completely understood.”

FDA’s statement noted that the therapy was associated with some increased risk of atrial fibrillation that required hospitalization, although this was greater among patients with a history of this condition. Patients who were also taking certain medications, such as aspirin, warfarin, or clopidogrel, had increased bleeding risk. Patients who have allergies to fish or shellfish can have allergic reactions.

Side effects included joint pain, musculoskeletal pain, peripheral edema, and atrial fibrillation.