By RTT News,
January 21, 2014, 01:18:00 AM EDT
(RTTNews.com) - Amarin Corporation plc ( AMRN ) announced that the Division of Metabolism and Endocrinology Products, or DMEP, within the U.S. FDA has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement."
DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa (icosapent ethyl) 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease.
The company plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II. Amarin does not expect a determination on the pending ANCHOR supplemental new drug application (sNDA) while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
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