Amarin Corp., which has its R&D base in Stonington, said the U.S. Food and Drug Administration has declined to accept its appeal of a decision late last month to rescind an agreement regarding its drug trial of Vascepa.
On Oct. 29, the FDA repealed an agreement with Amarin that allowed the company to pursue a trial testing the drug — which lowers triglycerides in the blood — on patients taking statin drugs, such as like Lipitor. The agreement was a guarantee that the company’s trial design was acceptable to the FDA.
Vascepa is approved for patients not taking statins.
