Amarin's fish-oil derivative Vascepa scored a major FDA win in December as a heart-helping add-on to statins in patients with high triglyceride levels or established cardiovascular disease. Despite the win, researchers were unsure how to explain Vascepa's underlying CV outcomes data––but now they might have an answer.
Patients treated with 4-gram daily doses of Vascepa showed a 386% increase in blood serum levels of EPA, an omega-3 fatty acid, over placebo while also posting a 25% risk reduction in CV events, according to an analysis of Amarin's phase 3 Reduce-It trial presented Monday at the American College of Cardiology scientific sessions.
In patients with the highest levels of EPA in their blood, researchers found a significant reduction in hospitalizations for new heart failure with the drug compared with placebo and lower risks of sudden cardiac death and heart attack.
The newest study helps fill in the blanks on the mechanism of action for Vascepa, originally approved to lower abnormally high triglyceride levels but sporting a major CV label update after an FDA decision in December.
In December, the FDA approved Vascepa as an add-on to statins to reduce the risk of cardiovascular events in patients with elevated triglycerides who have either established CV disease or diabetes with two additional CV risk factors. The FDA based its decision on a major outcomes trial from last year showing the drug on top of statins cut the risk of CV events by 25% in patients with abnormally high triglyceride levels.
With that much-anticipated label expansion in hand, Amarin rolled out a newly doubled sales force of 800 reps to help get the message out and cue a bump in sales, starting primarily in the second quarter.
However, earlier this month, Amarin said it would sideline that field force amid the novel coronavirus pandemic, hoping to limit face-to-face interaction between sales reps and doctors.
Now that Amarin's boosted sales force is largely offline––the company will still be sending digital educational materials, copay cards and samples by mail––investors can expect "scripts and sales will flatten or possibly decline since patient volumes and doctor and pharmacy visits will decline," Jefferies analyst Michael Yee wrote in a note to clients.