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Amarin: Cardiovascular Outcomes Study Of Vascepa Capsules Met Primary Endpoint

Amarin Corporation plc (AMRN) announced Monday that the Vascepa cardiovascular or CV outcomes trial, REDUCE-IT, met its primary endpoint.

In pre-market activity on Nasdaq, Amarin shares were surging around 163.6 percent to trade at $7.88.

The company noted that REDUCE-IT, a global study of 8,179 statin-treated adults with elevated CV risk, demonstrated an approximately 25% relative risk reduction, to a high degree of statistical significance, in major adverse CV events or MACE in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo.

This result was supported by robust demonstrations of efficacy across multiple secondary endpoints.

Vascepa was well tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling. The proportions of patients experiencing adverse events and serious adverse events in REDUCE-IT were similar between the active and placebo treatment groups. Median follow-up time in REDUCE-IT was 4.9 years.

Amarin said it is eager to share REDUCE-IT data in greater detail with both the medical community and regulatory authorities. REDUCE-IT results have been accepted for presentation at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois.

The presentation is classified as late breaking clinical trial results, which was granted based on the ability of REDUCE-IT to address a critical question in cardiovascular prevention.

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