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Amarin announced primary results from Vascepa cardiovascular outcomes trial

Amarin announced the primary results from the Vascepa cardiovascular outcomes trial, REDUCE-IT, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association in Chicago, Illinois. REDUCE-IT primary results confirmed 25% relative risk reduction for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death. Cardiovascular benefits appeared not to be influenced significantly by triglyceride levels at baseline or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline.

REDUCE-IT was a global study of 8,179 statin-treated adults with elevated CV risk. Many patients with well-managed LDL-C remain at high risk for cardiovascular events. No therapy is currently approved to treat the residual risk in REDUCE-IT patients and no other therapy has demonstrated a 25% risk reduction on top of statin therapy in a major cardiovascular outcomes trial. REDUCE-IT studied Vascepa 4 grams/day as compared to placebo over a median follow-up time of 4.9 years. The REDUCE-IT study was designed under a special protocol assessment agreement with the U.S. Food and Drug Administration.

Amarin intends to submit an sNDA to the FDA in early 2019 seeking approval to expand the label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study. FDA's determination of standard or priority review will be made when the sNDA is submitted. At this time, Amarin is planning for a standard review with potential approval anticipated in late 2019. Vascepa is a low-cost drug. The majority of patients covered by insurance who obtain prescriptions for Vascepa pay a monthly co-pay charge of $9.99 or less. A patient with commercial insurance can pay as little as $9 for a 90-day supply prescription of Vascepa.

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