Amarin Corp Plc (AMRN)

[Biobillionair]

Anchor to be posted on Label

This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf