Supplemental New Drug Application (sNDA) for icosapent capsules (VascepaT) for hypertriglyceridaemia and mixed dyslipidaemia

Source: BioSpace Area: News Amarin Corporation has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for icosapent ethyl capsules (VascepaT) for use as an adjunct to diet in the treatment of adult patients with hypertriglyceridaemia (triglyceride (TG)  =200 mg/dL and <500 mg/dL) with mixed dyslipidaemia.   The FDA has approved the product (an ultrapure capsule containing  96% eicosapentaenoic acid), as an adjunct to diet to reduce TG  levels in adult patients with severe hypertriglyceridaemia (TG ?500mg/dL/ 5.69 mmol/L).   [Editors note: Icosapent ethyl capsules are not licensed within the EU.]
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news