With its blockbuster hopes in question after a catastrophic patent loss, Amarin's Vascepa continues to pique investigators' interest over how exactly it cuts patients' cardiovascular risks. New data from an investigator-sponsored imaging study could provide a clue.
Vascepa cut patients' coronary plaque by 17% over baseline in an 18-month imaging study investigating the mechanism of action behind the pill's FDA-approved CV risk benefits, according to late-breaking science presented Saturday at the European Society of Cardiology's virtual annual meeting.
Patients treated with a daily 4-gram dose of Vascepa after statins saw a significant reduction in plaque levels, a potential clue behind how the fish-oil derivative helps cut the risk of major cardiovascular events in patients with abnormally high triglycerides and preexisting cardiovascular disease. Patients in the placebo-control arm, by contrast, saw increased levels of low-attenuation plaque at the 18-month mark.
The 18-month findings followed nine-month interim data from the Lundquist Institute study presented in November.
Vascepa notched an FDA approval in December to include its heart-helping benefits on its label, which at the time marked a potential blockbuster label expansion. The agency based its review on Amarin's Reduce-It outcomes study, which showed that Vascepa cut the risk of major CV events by 25% over placebo.
One of the lingering unknowns from that trial—the effect of a mineral oil placebo, rather than a traditional placebo, on patient outcomes—was addressed in the Evaporate study, which found the mineral oil pill had no significant effect at reducing arterial plaque over another placebo.