The Food and Drug Administration (FDA) has approved icosapent ethyl (Vascepa, Amarin) to reduce the risk for cardiovascular (CV) events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors, the agency announced today.
The indication applies to use of the purified, high-dose marine-oil preparation as an add-on option for patients on maximally tolerated statins. The FDA says the approval is the first for an agent with its specific indication.
Vascepa was approved in 2012 for the reduction of elevated triglycerides. The new approval is based largely on the REDUCE-IT trial's finding of a 25% reduction in risk for major adverse CV events in patients like those in the indication compared with a placebo-control group.
The drug had received a unanimous thumbs-up for the CV-risk-reduction indication from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in November.
Cite this: FDA Approves Amarin's Vascepa for Cardiovascular Risk Reduction - Medscape - Dec 13, 2019.