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Amarin Corporation PLC announces FDA review division response to ANCHOR SPA agreement reinstatement request


Tuesday, 21 Jan 2014 01:00am EST 

Amarin Corporation PLC:Says that the division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) has notified Amarin in connection with Amarin's request for reconsideration of DMEP's Oct. 2013.decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement that DMEP 'does not plan to re-instate the ANCHOR SPA agreement.Says that in its communication to Amarin, 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.Says 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. 

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1.58
0.06 +3.95%
22 Jul 2014