FDA Delays Decision on Expanded Labeling for Vascepa (Icosapent Ethyl)
Omega-3 product reduces triglyceride levels (December 20)
The FDA has notified Amarin Corporation that it does not expect to take action on the company’s supplemental new drug application (sNDA) for a proposed labeling expansion for Vascepa (icosapent ethyl) capsules to include a broader patient population on the December 20, 2013 Prescription Drug User Fee Act (PDUFA) goal date.
In October, the agency revoked an agreement guaranteeing that the design of a late-stage trial of Vascepa was adequate to support a marketing application, and Amarin appealed for a review. In the new notification, the FDA informed the company that since the appeal remains under consideration, it decided to take no action on the approval for expanded use. No new PDUFA date was established.
The FDA also communicated to Amarin that it views the company’s appeal as a separate administrative decision. The agency plans to complete its review of Amarin’s request to re-instate the late-stage trial agreement and will convey its decision to the company no later than January 15, 2014.
Vascepa (icosapent ethyl) was approved in 2012 for use as an adjunct to diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. The new sNDA seeks approval of the drug for use as an adjunct to diet and exercise for adult patients receiving statin therapy with mixed dyslipidemia (one or more lipid disorders) and triglyceride levels between 200 and 499 mg/dL.
Icosapent ethyl, known in the scientific literature as AMR101, is an eicosapentaenoic acid (EPA) omega-3 prescription product in a 1-gram capsule.