From Dyslipidemia to Cardiac Risk Prevention
With New SPA for Fish Oil Drug, Amarin is on its Way
By Catherine Shaffer
Amarin Corp. plc and the FDA have reached an agreement on a special protocol assessment (SPA) for the design of a cardiovascular outcomes study (REDUCE-IT) of AMR101. The drug, a prescription-grade fish oil, has already turned in impressive results for dyslipidemia in two previous Phase III trials.