Feb 6, 2020: Amarin Corporation plc announced that BioNJ awarded Amarin with an Innovator Award in recognition of the approval of a new indication for VASCEPA® (icosapent ethyl) by the U.S.FDA in December 2019.
This approval places VASCEPA as the first and only approved drug for minimizing cardiovascular events in millions of select patients at high risk.
The approval follows a decade of research and development in a clinically complex field of the disease marked by significant unmet medical needs.
“BioNJ is happy to present Amarin with the Innovator Award for its dedication to expanding this affordable and innovative therapy, VASCEPA, for use to reduce cardiovascular risk,” said Debbie Hart, president and chief executive officer of BioNJ.
“Amarin has clearly demonstrated that it is a committed corporate citizen and is dedicated to the continued expansion of the biotech industry in the State of New Jersey.”
The success of VASCEPA as a recognized new, cost-effective therapy in order to reduce cardiovascular risk has propelled Amarin’s growth from a dozen employees in 2011 to its current size of more than 1000 people in the United States and Ireland, more than 100 of whom are in New Jersey.
In its important new cardiovascular risk reduction designation, Amarin’s successful completion of the groundbreaking REDUCE-IT ® clinical trial was the basis for VASCEPA’s FDA-approval.
In this review of statin therapy patients who had specific cardiovascular risk factors amid wellcontrolled cholesterol, VASCEPA showed a significant 25 per cent reduction in major adverse cardiovascular events beyond the advantages of the existing medical norm.
In recognition of these extraordinary results, VASCEPA received a 16-0 vote in favor of the approval by the FDA Endocrinologic and Metabolic Drugs Advisory Committee, with subsequent approval granted by the FDA.
