- Six months after results from a high-profile study of Amarin's heart drug Vascepa impressed, researchers on Monday unveiled data showing an even greater clinical benefit to the fish oil-derived pill.
- Vascepa reduced the total number of cardiovascular events, such as heart attacks or stroke, by 30% compared to placebo in statin-treated patients, according to a newly released post-hoc analysis. That figure is greater than the study's topline result, which showed a 25% relative risk reduction of the first occurrence of a major adverse cardiovascular event.
- "By looking only at first events, we underestimate the true underlying treatment benefit offered," Deepak Bhatt, the study's leader author, said in a statement, adding the "impact on total events is what matters most." Bhatt presented the findings at the American College of Cardiology's annual conference in New Orleans.
The fresh analysis could excite those on the financial side and further intrigue scientists, but the fresh data doesn't yet resolve the larger questions that have surrounded Amarin's Vascepa (icosapent ethyl).
After the full dataset was released last November, a debate emerged in the cardiology space over what to make of Vascepa. Some cardiologists raised questions on the potential impact the mineral oil placebo may have had, particularly given elevated levels of two key biomarkers among the control group. And others remain puzzled over how the drug actually works.
Amarin's Phase 3 study tested more than 8,000 patients with a median follow-up time of nearly five years. Those enrolled had elevated cardiovascular risk levels and were already on statins.
Monday's analysis found Vascepa had a larger relative risk reduction in preventing multiple cardiovascular events. While treatment resulted in that previously announced 25% reduction for first events, the new results showed Vascepa also lowered the chance of a second event by 32%, a third event by 31% and a fourth or greater event by 48%.
Amarin's stock surged higher following the topline results last fall and have remained elevated. Shares opened Monday trading at $21.23 apiece, up more than 500% compared to price levels before the initial readout in September.