AHA 2018 – Amarin rages against Vascepa but questions remain

Amarin made waves in September, announcing her victory in the test-reduction of her purified fish oil product, Vascepa. The comprehensive data, presented yesterday at the meeting of the American Heart Association in Chicago, added an impressive advantage over the more challenging cardiovascular settings.

However, some feared that the mineral oil pill used as placebo resulted in a worsening of "bad" cholesterol, with some fearing that this has helped to boost the benefit in the Vascepa group. Amarin dispelled these concerns. Rebecca Juliano, vice president of clinical R & D, repeated several times during a conference call yesterday that Reduce-This was an attempt to evaluate the results rather than detect a difference in biomarkers.

Good

And, purely on the results, reduce-it looks good. AHA participants already knew that the trial had achieved its primary goal: Vascepa administered over statins reducing the risk of cardiovascular events by 25% (Amarin disembarks the taking of a life, September 24, 2018).

The figures reported yesterday showed a five percentage point gain in the Vascepa group on this measure: 17% of treatment arm patients experienced an event compared to 22% in the placebo group.

Nevertheless, this measure was a five-point composite with "more moderate" parameters such as angina. What mattered most to investors was whether there was an advantage over more "hard" components such as cardiovascular death, and these data also appeared positive.

Yesterday, Reduce-It announced a victory over the more stringent composite assessment criterion MACE-3, the main secondary endpoint, showing a 26% relative reduction in the risk of cardiovascular death, d & # 39; nonfatal myocardial infarction or nonfatal stroke due to Vascepa.

This was well above the 15% target that Jefferies analysts had set in anticipation of the AHA meeting. On this measure, 11% of patients treated with Vascepa and 15% of patients who received placebo had an event.

And Reduction-It has touched all its pre-specified secondary parameters, except death from all causes, which was analyzed last in the hierarchy.