There’s something fishy about the positive results Amarin reported for its supplemental drug, Vascepa.
In September, the company released preliminary results from the study showing that its purified fish oil drug reduced the risk of several serious cardiovascular events by 25 percent. The findings stood in contrast to several other studies showing that fish oil supplements did not significantly improve heart health.
Analysts predicted that sales for Vascepa, which has already been indicated to treat high triglyceride levels, could reach blockbuster levels as high as $1 billion annually by 2023.
But this weekend, further details about the study were released, casting doubt over the trial’s design. In particular, cardiologists have raised concerns about the company’s use of mineral oil as the placebo for the trial, which involved 8,179 patients. According to the study, blood tests from the patients who received mineral oil showed elevated levels of low-density lipoprotein (or LDL — the bad cholesterol), which could have triggered more negative cardiovascular outcomes, and skewed the results.
The new findings have since incited public debate among cardiologists about the efficacy of Vascepa. Some have indicated that the latest revelations could create a serious hurdle to the medical community embracing the drug, while others have attributed the patients’ rise in LDL levels to aging and other factors.
And as Amarin moves ahead with its quest to get its fish oil drug approved for a wider range of heart conditions, a goal it has set for early next year, it appears the company could be in deep water.
Read the full Forbes report.