Received complete response letter from FDA regarding Vascepa - filing
Amarin Corporation plc announced today receipt of the anticipated Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Vascepa(icosapent ethyl) capsules ANCHOR trial supplemental New Drug Application (sNDA). Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia. Current Vascepa labeling remains unchanged. The ANCHOR sNDA sought to expand approved Vascepa labeling to include use as an adjunct to diet to reduce TG levels in adult patients on statin therapy with mixed dyslipidemia (one or more lipid disorder) and triglyceride levels from 200 to 499 mg/dL, the ANCHOR population.As previously guided by Amarin, the CRL has been expected in recent months following Amarins determination to not further appeal the October 2013, FDA ANCHOR Special Protocol Assessment (SPA) agreement rescission after the reconsideration and denial of the rescission appeal at three levels of increasing authority within the FDA. The originally assigned Prescription Drug User Fee Act, or PDUFA, goal date for the completion of the ANCHOR sNDA was December 20, 2013.In the CRL, FDA acknowledged that Vascepa yielded a treatment difference showing reduced TG levels compared to placebo in patients treated in the ANCHOR study. The clinical rationale for reducing serum TGs with Vascepa and modifying other lipid/lipoprotein parameters shown in ANCHOR among statin-treated patients with TGs 200-499 mg/dL is to reduce cardiovascular risk. FDA concluded that, for regulatory approval purposes, there are insufficient data at this time to support a drug-induced change in serum TGs as a surrogate for reducing cardiovascular risk in the ANCHOR population. FDA did not determine that the drug-induced effects of Vascepa, which go beyond TG-lowering, would not actually reduce cardiovascular risk in this population. Amarin had proposed to FDA multiple alternative indications, data presentations, disclaimers and other regulatory pathways to approval under the sNDA, but FDA determined not to approve label expansion reflecting the ANCHOR clinical trial efficacy data at this time. Safety data from the ANCHOR study remains in the currently approved label for Vascepa.