Will FDA approve Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s Vascepa?

Posted by Ryan Mandell October 10, 2013 0 Comment 1239 views

Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced that the United .States Food and Drug Administration has now scheduled an advisory committee meeting. This meeting will be held on 16 October 2013 and will be in connection with the Vascepa ANCHOR indication. There have been certain lapses in appropriations from the Federal Government. Despite this the meeting will be conducted as has been previously suggested.

Wednesday’s trading

In Wednesday’s trading, Amarin Corporation plc (ADR) (NASDAQ:AMRN) dropped by 5.83%. The opening price of the shares was $6.82, which climbed to an intraday high of $6.83 and dipped to a close of $6.30. Approximately 10.88 million shares were traded on Wednesday while an average volume of 5.24 million shares were traded over a 30 day period. The 52-week low of Amarin Corporation plc (ADR) (NASDAQ:AMRN) shares is $5.12 and its 52-week high is $12.96. The company has a market capitalization of $1.08 billion.

About the company

Amarin Corporation plc (ADR) (NASDAQ:AMRN) is a late stage bio-pharma company. It has expertise in lipid-science that is focused on treating cardiovascular disease. AMR101, its product candidate is one ultra-pure Omega 3 fatty-acid. The company is developing AMR101 to be used for treating patients suffering from high triglyceride levels, which is also called hypertriglyceridemia.

In 2011 September, Amarin Corporation plc (ADR) (NASDAQ:AMRN) filed a New Drug Application, with the U.S Food and Drug Administration. In 2011 December, it started patient-dosing in its cardiovascular-outcomes study for AMR101. This study was called REDUCE-IT.

A pivotal trial

The MARINE trial is carried out with Omega 3 fatty-acids and is used in the treatment of patients suffering from extremely high triglycerides. This is a multi-center, Phase-III, randomized, placebo-controlled, double-blind, 12 week study. Patients who were enrolled in this trial had been given the option to get treated with AMR101 for up-to 40-weeks after the last-dose in this pivotal trial.

About Ryan Mandell

Ryan Mandell is our senior staff writer covering the White House for Political Report, Ryan also coordinates with the main newsroom news items and contributing write-ups on cultural, social and political activities. Ryan holds an undergraduate degree in journalism, a Doctorate in international relations and a Master Degree in mass communications with an emphasis in print journalism. Ryan also covered the International Society of Social Defense congress in Spain in 2007 and taken part in the Global Forum on economic policies

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