Amarin submits sNDA to FDA for new Vascepa cardiovascular risk indication

Amarin announced that, as planned, it submitted a supplemental new drug application, sNDA, to the U.S. Food and Drug Administration seeking an expanded indication for its lead product, Vascepa capsules, based on the landmark REDUCE-IT cardiovascular outcomes study1, 2. As is typical, while the FDA acknowledged receipt of the sNDA 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 sNDA will be reviewed on a standard review clock of ten months resulting in a PDUFA date near the end of January 2020.”This submission is another step forward toward our goal to help address the risk of cardiovascular disease,” said John F. Thero, president and chief executive officer of Amarin.” The REDUCE-IT results support that approximately 1 fewer major cardiovascular adverse event would occur on average for every 6 patients treated with Vascepa for 5 years on top of statin therapy compared to placebo1. This unprecedented result beyond cholesterol management presents an important new preventative care opportunity for millions of patients.”
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