PHILADELPHIA—One year after a cardiovascular outcomes study for Amarin’s Vascepa took the American Heart Association’s (AHA’s) Scientific Sessions by storm, the fish-oil pill is back—and on the verge of something big.
With an FDA decision to expand Vascepa’s label to include CV risk reduction looming, a new imaging study now shows Vascepa could have an effect on stopping the progression of plaque in the arteries. Those results, which help explain Vascepa’s mechanism of action, could give physicians even more reason to prescribe the drug if it nabs its expanded label.
Patients treated with a daily four-milligram dose of Vascepa after statins showed an across-the-board slowing of plaque buildup, according to a nine-month interim analysis from the Lundquist Institute’s Evaporate imaging study, presented Monday at the AHA annual meeting. Vascepa also slowed the progression of coronary atherosclerosis, Amarin said.
The Evaporate data help fill in the blanks for how Vascepa works after the drugmaker’s Reduce-It outcomes trial showed a 25% risk reduction of cardiovascular events in patients with abnormally high triglycerides, according to Amarin Chief Medical Officer Craig Granowitz.
“The idea was to look and use imaging and say, ‘Is there an intermediate step linking a cardiovascular outcome back to some other physical process?'” Granowitz said. “To begin to look at the mechanism of action in a clearer way is very important.”
“There was a lot of tumult in the field this year, and I think it’s incredibly healthy and representative of vigorous academic debate and dialogue to have a really open and democratic discussion on a worldwide basis … to put this data into context,” Granowitz said. “The end result of that is I think there was a really broad consensus that these study results are real and these results are believable and profound.”
A few things are left to be determined, however, in the FDA’s labeling decision. The major decision will be whether Vascepa should be indicated as a primary preventive for patients without established cardiovascular disease rather than a reactive drug in patients already diagnosed.
A second question is whether the label should include CV death after the committee expressed skepticism that the drug showed enough efficacy in its trial data.