FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Grants Priority Review to Amarin’s Cardiovascular Drug

June 6, 2019

The FDA granted priority review to Amarin’s Vascepa, a drug design to cut the risk of cardiovascular disease.

If approved, Vascepa (icosapent ethyl) would be the first drug of its kind on the U.S. market. It targets the residual heart disease risk for patients who manage their cholesterol with statins but still have continuing problems with high triglycerides.

The accelerated approval comes after Amarin handed up data from its REDUCE-IT trial, which were also published in the New England Journal of Medicine last year. The study of more than 8,100 patients found that participants  in the Vascepa group saw a 26 percent reduction in the risk of a stroke, heart attack or unstable angina.

Amarin expects to hear the FDA’s decision by Sept. 28.

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