The FDA has approved Amarin’s Vascepa—icosapent ethyl—to reduce cardiovascular risk beyond cholesterol-lowering therapy in high-risk patients, making it the first drug of its kind to be approved in the U.S.
Amarin announced the expanded indication and label for Vascepa on Dec. 13, noting that after “more than a decade of development and testing,” its icosapent ethyl capsules are the first and only solution approved as an adjunct to maximally tolerated statin therapy to reduce the risk of MI, stroke, unstable angina and coronary revascularization in patients with elevated triglycerides and established CVD. The company estimates that millions of high-risk patients in the U.S. could benefit from the therapy.
“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,” 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 three decades ago. Many patients stand to benefit from this historic advance in care.”
Bhatt was lead investigator of the REDUCE-IT study, which served as the basis for the FDA’s expanded indication. In REDUCE-IT, patients taking Vascepa to control their lipid levels saw a 30% risk reduction in total major adverse cardiovascular events compared to their counterparts taking a placebo.
Amarin said in its December release that it intends to “promptly” launch Vascepa in the U.S. with the new indication.
“We look forward to helping educate physicians and patients on the value of Vascepa,” John F. Thero, president and CEO of Amarin, said in the statement. “The expanded indication and related clinical study labeling is broadly worded, informative of 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.”