FDA Accepts Amarinâ€™s AMR101 NDA Filing
The acceptance of the NDA reflects the federal agencyâ€™s determination that the application is sufficiently complete to permit a substantive review.
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.
â€œWe 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,â€ said Joseph Zakrzewski, chairman and CEO of Amarin.
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.
AMR101 is comprised of not less than 96 percent ultra pure EPA (icosapent ethyl), that Amarin is developing for the treatment of patients with very high triglyceride levels (>=500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>=200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Triglycerides are fats in the blood.
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