Dallas, Texas 02/03/2014 (FINANCIALSTRENDS) – The Ireland based $311 million market capped drug maker Amarin Corporation plc (ADR) (NASDAQ:AMRN) faced a sever push back in its efforts to get FDA approval on a additional treatment line on its drug candidate Vascepa. The set back was in the form of a rejection by the Division of Metabolism and Endocrinology Products of drug firms request to reconsider its October 2013 decision of not approving Vascepa for a new strain of treatment. Division of Metabolism and Endocrinology Products is a statutory body set up by the U.S. Food and Drug Administration to review the data provided by drug firms and provides recommendations on technical aspects of the drugs in question to FDA.
It is appropriate to note here that last year Division of Metabolism and Endocrinology Products had voted against the introduction of new indication of the target drug Vascepa as an addition to existing treatment of adults suffering from high triglyceride levels. In its detailed reasoning for the rejection of the request, the board has clarified that the available data does not conclusively support the use of the target drug in reducing triglyceride.
Expressing its disappointment about the rejection, the small capped drug maker released a press brief in which, it has explained its next course of action thus. “We note that Vascepa is already approved in the U.S. as an adjunct to diet for reducing triglyceride levels in adults suffering from severe hypertriglyceridemia (triglyceride ≥ 500mg/dL). We now plan to appeal to the FDA Director of the Office of Drug Evaluation II (ODE-II) against the DMEP decision.”
It is important to note here that Amarin Corporation plc (ADR) (NASDAQ:AMRN) is already pursuing a new drug application for a compete new indication called MARINE. The application was accepted by FDA in 2013 and is pending review by the board.