Biopharmaceutical company Amarin has submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking approval for the marketing and sale of its Vascepa(R) (icosapent ethyl) capsules.
Vascepa is used as an adjunct to diet in the treatment of adult patients with high triglycerides (TG >=200 mg/dL and <500 mg/dL) with mixed dyslipidemia.
Amarin is expecting to hear FDA's decision within 74 days, whether the sNDA submission has been accepted for review.
Amarin chairman and chief executive officer Joseph Zakrzewski said the company's sNDA for Vascepa submission follows the FDA approval and recent launch of Vascepa for use as an adjunct to diet to lower triglyceride levels in adult patients with severe (TG >=500 mg/dL) hypertriglyceridemia.
"If approved for the ANCHOR indication, Vascepa will be the only approved prescription omega 3 therapy for cardiovascular health management in this patient population (TG >=200 mg/dL and <500 mg/dL with mixed dyslipidemia) and will represent the next generation of lipid management for potentially millions of patients," Zakrzewski added.
