"We are very pleased with the FDA's acceptance for filing of our AMR101 NDA submission as it is a significant achievement in the development of what we believe is a next generation omega 3 based triglyceride lowering therapy," said Joseph Zakrzewski, chairman and CEO of Amarin.
Amarin's NDA, submitted to FDA on September 26, 2011, seeks approval to market and sell AMR101 in the U.S. for the indication studied in the MARINE trial—the treatment of patients with very high triglycerides (≥500mg/dL). The NDA for AMR101 is supported by data from both Phase 3 AMR101 clinical trials, MARINE and ANCHOR, in which trials AMR101 achieved all of the primary endpoints and was well tolerated with a safety profile comparable to placebo.
The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. The PDUFA date is the goal date for the FDA to complete its review of the NDA.