Amarin share prices nearly quadrupled after the biopharma's fish oil capsule showed dramatic benefits to heart patients in a clinical trial.
In a trial involving 8,179 statin-treated adults with elevated cardiovascular risk, Vascepa significantly reduced serious cardiovascular events over a placebo.
Currently, Vascepa is FDA-approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
“Considered against the backdrop of multiple unsuccessful cardiovascular outcomes studies of earlier generation drug therapies, including multiple recent failed cardiovascular studies of omega-3 mixture products that contain the omega-3 acid DHA, REDUCE-IT topline results stand alone as positive and confirm our hypothesis that pure EPA Vascepa at 4 grams/day can provide additional cardiovascular risk reduction benefit on top of LDL-C control with standard of care statin therapy in studied patients,” said Craig Granowitz, MD, PhD, senior vice president and chief medical officer of Amarin.
Taking the recent REDUCE-IT trial results into consideration, Amarin plans to expand its sales force in the United States, and work with its international partners to support regulatory efforts outside the United States.
Read the press release