The biopharma company Amarin surprised critics with the results of the REDUCE-IT (Reduction of Cardiovascular Events With EPA-Intervention Trial) study, which showed that its proprietary, prescription formulation of fish oil, called Vascepa, significantly reduced the risk of deaths, heart attacks, strokes, and other serious cardiovascular events compared to placebo. Amarin designed its cardiovascular outcomes study hoping to show that Vascepa could meet the primary endpoint with a 15% risk reduction. The findings showed a highly statistically significant 25% risk reduction in high-risk patients, and without side effects.
Amarin has been working on this trial for the better part of a decade, despite the fact that many previous fish-oil trials have failed over the years. Amarin has long maintained that the special characteristics of Vascepa—namely the fact that it contains only highly purified EPA, the most beneficial omega-3 fatty acid—enable it to allow for a higher dose without raising cholesterol, as some other fish oils can. Amarin theorized that focusing on high-risk patients with persistently high triglycerides would reveal the benefit of its 4-gram daily dose (higher than that of competitors), and the study results appear to support the hypothesis.
Insurers already approve coverage of the drug for use by a small group of patients with very high triglycerides, but there is now a case to be made to expand coverage more broadly. Vascepa’s list price is currently about $2,400 a year, much lower than other FDA-approved cardiovascular drugs. That relatively low price, combined with the number of people who could benefit from the drug, and the size and rigor of the trial, will make aggressive restriction difficult.
Some skepticism about previous failures and Amarin’s claims that its drug’s purity is difficult to replicate will remain, and so far the company has not disclosed data on important secondary endpoints. More data will be presented at the upcoming American Heart Association annual meeting.
Source: STAT, September 24, 2018