Irish drug developer Amarin Corp. PLC, with clinical-stage research based in Stonington, has cleared some of the remaining hurdles before it can formally submit to federal drug authorities by late September its application to market a therapy for patients with high blood levels of heart-damaging fatty acid.
Amarin said Thursday it completed a 26-week study into whether its AMR101, a synthetic omega-3 fatty acid treatment, caused cancer in lab mice. It was the last of two required carcinogenicity studies the Food & Drug Administration requires of applicants, the company said.
Dublin-based Amarin says it also successfully completed its final in-vitro studies supporting the non-clinical package for the drug application.
“Successful completion of these studies is important progress as they represent necessary studies to support our … submission,” Amarin Chairman and CEO Joseph Zakrzewski said in a statement.
