The FDA will not take action on Amarin‘s sNDA for Vascepa (icosapent ethyl) capsules by the Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2013. The delay is due to Amarin’s request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement remains under consideration with the FDA. No new PDUFA date was established.

The FDA also communicated to Amarin that it now views Amarin’s appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin’s request to re-instate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA.

Vascepa is currently FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia. The ANCHOR sNDA seeks approval of Vascepa for use as an adjunct to diet and exercise for adult patients on statin therapy with mixed dyslipidemia (one or more lipid disorder) and triglyceride levels between 200 and 499 mg/dL.