Amarin defends Vascepa's CV-prevention data against supplement makers eager to cash in

Amarin spent years, millions of dollars and a lot of willpower proving its fish oil-based drug Vascepa really could cut the risk of heart attacks, strokes and other cardiovascular problems. To make that effort pay off, it needs to keep that proof to itself.

That's just what the drugmaker did in settling two lawsuits with fish oil supplement manufacturers who'd allegedly co-opted the results of Amarin's landmark Reduce-It trial. And in touting its double win, Amarin said it has lawyers "on speed dial" to keep fighting off supplement makers that equate their products to Vascepa’s purified Omega-3 fatty acid formulation.

As it defends itself on the rear, Amarin is pushing forward on a Vascepa label extension to highlight the Reduce-It data filed with the FDA in March. Those data showed Vascepa lowered the risk of a major adverse CV event by 26% in previously untreated patients compared with placebo, and by 30% in statin-treated patients at a median follow-up of 4.9 years.

Vascepa’s clinical win—which one analyst called a "breakthrough" in cardiovascular prevention—dovetailed with Amarin’s impressive first-quarter growth. The drug posted an 80% prescription jump in the first quarter, and sales leapt to $73.3 million from $43.9 million in the same period last year, CEO John Thero said during an earnings call with analysts.

Despite its strong sales performance, though, Thero urged caution, saying the company’s forecasted growth could be delayed by physicians slow to buy in on Vascepa.

"It may also take more time for some doctors to begin prescribing Vascepa, as the label for Vascepa has not yet been expanded and because such doctors have not had a practice-changing new therapy for preventative cardiovascular care in many years beyond therapies for cholesterol management and diabetes," he said.

Amarin may also have to contend with experts who questioned Vascepa’s clinical data after accusations that the study’s placebo control might have increased the risk of adverse CV events in the patient pool.

After patients in the control arm of the Reduce-It trial showed CV biomarkers trending toward higher heart risks, critics said the placebo was skewing Vascepa’s data. Patients who got the dummy pill saw their levels of bad cholesterol—usually associated with higher heart risks—increase around 10% in the first year versus changes of less than 3% in the Vascepa group. Levels of high-sensitivity C-reactive protein—an indication of inflammation—also increased 30% in the placebo group.

But in a post hoc analysis, investigators found the magnitude of effect on major adverse cardiac events was the same between those whose low-density lipoprotein level increased and those who experienced a decline—meaning the adverse biomarkers had little effect on the final results.

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