NDA Accepted for AMR101 for Hypertriglyceridemia
Amarin announced that the FDA has accepted for filing its New Drug Application (NDA) for AMR101 for 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 AMR101 achieved all of the primary endpoints and was well tolerated, with a safety profile comparable to placebo.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra-pure EPA (icosapent ethyl).
For more information call (908) 719-1315 or visit www.amarincorp.com.