Posted by Michael Wonder on 29 May 2019
U.S. FDA grants priority review for Vascepa (icosapent ethyl) supplemental new drug application seeking cardiovascular risk reduction indication
29 May 2019 - PDUFA date assigned is 28 September 2019, four months sooner than expected.
Amarin Corporation announced today that its supplemental new drug application for Vascepa (icosapent ethyl) capsules has been accepted for filing and granted priority review designation by the U.S. FDA.
Assuming FDA approval, Vascepa will be the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides, an important indicator of cardiovascular disease. This is a serious health challenge experienced by millions of people.
