Posted by Michael Wonder on 29 Mar 2019
Amarin submits supplemental new drug application to U.S. FDA seeking new indication for Vascepa (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on landmark REDUCE-IT cardiovascular outcomes study
28 March 2019 - Amarin Corporation today announced that, as planned, it submitted a supplemental new drug application to the U.S. FDA seeking an expanded indication for its lead product, Vascepa (icosapent ethyl) capsules, based on the landmark REDUCE-IT cardiovascular outcomes study.
As is typical, while the FDA acknowledged receipt of the submission, at this stage FDA has not yet communicated to Amarin the intended timing of its review. Unless and until the company learns otherwise in communications from the FDA, the review timing is typically communicated within 60 to 74 days of the FDA’s receipt of an sNDA.
Amarin is operating under the assumption that the application will be reviewed on a standard review clock of ten months resulting in a PDUFA date near the end of January 2020.
