Advisory Committee recommends Vascepa to reduce the risk of cardiovascular events.- Amarin Corpn.

Amarin Corporation plc announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients based on results from the landmark REDUCE-IT cardiovascular outcomes trial. The FDA is not bound by the recommendations of an advisory committee. Amarin plans to work with the agency as it completes its review of the company�s application seeking an appropriate label expansion for Vascepa to reflect REDUCE-IT results.

Cardiovascular disease is the number one cause of death for men and women in the United States and the nation�s costliest disease, with direct and indirect expenses in excess of $500 billion each year. An independent drug pricing watchdog group concluded that Vascepa is cost effective for cardiovascular risk reduction as demonstrated in REDUCE-IT even under the most stringent standards of that group, a result rarely achieved in its analyses.