The US Food and Drug Administration (FDA) has accepted Amarin’s new drug application for AMR101 (icosapent ethyl), a drug to treat patients with very high triglycerides.
AMR101 is a prescription-grade omega-3 fatty acid, consisting of at least 96% ultra pure icosapent ethyl.
The application is backed by data from two Phase III AMR101 clinical trials, Marine and ANCHOR.
In the MARINE and ANCHOR trials, AMR101 met all primary endpoints and was well tolerated, with a safety profile comparable to placebo.
The MARINE trial evaluated AMR101 as a treatment for patients with very high triglycerides (=500mg/dl), while the ANCHOR trial investigated the drug for the treatment of patients on statin therapy with high triglycerides (=200mg/dl and <500mg/dl) with mixed dyslipidemia.
Both Phase III trials have been performed under special protocol assessment agreements with the FDA.
Amarin has already submitted a new drug application to the FDA seeking approval for the commercialisation of AMR101 for treatment of the patient population studied in the MARINE trial.
The company intends to separately seek approval for the population studied in the ANCHOR trial after its REDUCE-IT cardiovascular outcomes trial, which is currently underway.
The REDUCE-IT cardiovascular outcomes study is expected to be completed by the end of 2012, the company said.
Amarin chairman and chief executive officer Joseph Zakrzewski said the company believes that the new drug application approval from FDA will help them to further develop Omega-3-based triglyceride-lowering therapy.
The application is subject to a standard review and will have a Prescription Drug User Fee Act date of 26 July 2012.
Amarin is a late-stage biopharmaceutical company that specialises in lipid science, focusing on the treatment of cardiovascular disease.