Amarin announced that the FDA has accepted its Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200mg/dL and <500mg/dL) with mixed dyslipidemia. Vascepa (AMR101) is a pure-EPA omega-3 prescription product in a 1 gram capsule.
The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013.
Vascepa is already indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
For more information call (908) 719-1315 or visit www.amarincorp.com.